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General Events (10) Documents Activities (101) Votes (1) Amendments (209) History (39)
2014/0108(COD) Personal protective equipment
Lead IMCO FORD Vicky ( ECR) ARIMONT Pascal ( PPE), WESTPHAL Kerstin ( S&D), ROCHEFORT Robert ( ALDE), DURAND Pascal ( Verts/ALE)
Former Responsible Committee IMCO
Committee Opinion EMPL AGEA Laura ( EFDD)
Former Committee Opinion EMPL Guillaume BALAS ( S&D)
Former Committee Opinion ENVI
Former Committee Opinion ITRE
TFEU 114
2.10.03 Standardisation, EC/EU standards and trade mark, certification, compliance
4.15.15 Health and safety at work, occupational medicine
4.20 Public health
PURPOSE: to update internal market rules for personal protective equipment, in order to enhance consumer safety and ensure fair competition between companies.
LEGISLATIVE ACT: Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC.
CONTENT: the new Regulation updates the existing rules in directive 89/686/EEC. It lays down requirements for the design and manufacture of personal protective equipment (PPE), which is to be made available on the market, in order to ensure protection of the health and safety of users and establish rules on the free movement of PPE in the Union.
Scope: personal protective equipment offers protection against all kinds of hazards (e.g. heat, flames, chemicals, flying particles, mechanical shocks, etc.) in a range of different environments, whether it be the home, at work or on the sports field.
Examples include: head/ear/eye protection, breathing protection, body protection, and hand/leg/foot protection. Products intended for private use to protect against atmospheric conditions that are not of an extreme nature or to protect against damp and water, including dishwashing gloves, fall outside of the scope of the Regulation.
This Regulation covers PPE which is new to the Union market when it is placed on the market; that is to say, it is either new PPE made by a manufacturer established in the Union or PPE, whether new or second-hand, imported from a third country. It applies to all forms of supply, including distance selling.
Obligations of economic operators (manufacturers, importers, distributors): all economic operators intervening in the supply and distribution chain must take appropriate measures to ensure that they make available on the market only PPE which is in conformity with the Regulation. In particular, manufacturers must ensure that PPE has been designed and manufactured in accordance with the applicable essential health and safety requirements set out in Annex II. They must:
· implement the conformity assessment procedures established by the Regulation. These procedures are linked to the degree of risk involved;
· keep the technical documentation and the EU declaration of conformity for 10 years after the PPE has been placed on the market;
· carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring;
· ensure that the PPE which they place on the market bears a type, batch or serial number or other element allowing its identification;
· indicate, on the PPE, their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the PPE;
· ensure that instructions and safety information , as well as any labelling, is clear, understandable, intelligible and legible;
· further to a reasoned request from a competent national authority , provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the PPE with the Regulation, in a language which can be easily understood by that authority;
· immediately take the corrective measures necessary to bring PPE into conformity, to withdraw it or to recall it, as appropriate.
For their part, importers must make sure that they do not place on the market PPE which does not comply with requirements or which present a risk. They must also make sure that the conformity assessment procedures have been carried out and that the CE marking and technical documentation drawn up by manufacturers are available for inspection by the competent national authorities.
CE marking : the CE marking shall be affixed before the PPE is placed on the market and affixed visibly, legibly and indelibly to the PPE or affixed to the packaging and to the accompanying documents. The CE marking and, where applicable, the identification number of the notified body may be followed by a pictogram or other marking indicating the risk against which the PPE is intended to protect. Member States shall take appropriate action in the event of improper use of that marking.
Notifying authorities : the Regulation sets requirements for notifying authorities responsible for conformity assessment bodies. These bodies must apply the conformity assessment procedures without creating unnecessary burdens for economic operators . Interested parties have the right to appeal against the result of a conformity assessment carried out by a notified body.
Market surveillance : in the context of aligning the legislation on PPE with the new legislative framework for the marketing of products, and in order to ensure legal certainty, the rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to PPE covered by this Regulation.
The new Regulation also contains provisions regarding procedures at national level for dealing with PPE presenting a risk, Union safeguard procedures, and compliant PPE which presents a risk to health and safety.
Transitional provisions: Member States shall not impede the making available on the market of products covered by Directive 89/686/EEC which are in conformity with that Directive and which were placed on the market before 21 April 2019.
APPLICATION: from 21.4.2018, with the exception of certain provisions which apply from
21.10.2016 or from 21.3.2018.
DELEGATED ACTS: the Commission may adopt delegated acts in respect of amending the categories of risks against which the PPE is intended to protect users. The power to adopt delegated acts shall be conferred on the Commission for a period of 5 years (which may be tacitly extended) from 21 April 2018. The European Parliament or the Council may raise objections to a delegated act within two months from the date of notification (which may be extended by two months). If the European Parliament or the Commission raise objections, the delegated act will not enter into force.
The European Parliament adopted by 577 votes to 48, with 86 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council on personal protective equipment.
Parliament's position, adopted at first reading following the ordinary legislative procedure, amended the Commission proposal as follows:
Purpose and scope : the Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) which is to be made available on the market, in order to ensure protection of the health and safety of users .
Amendments aiming to include in the scope of the Regulation equipment to protect against cleaning materials of weak action or prolonged contact with water. Other substances and mixtures which are hazardous to health include atmospheres with oxygen deficiency and harmful biological agents which are now inserted into Annex I, Category III which includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health.
Excluded from the scope of the legislation are PPE:
designed to be used for self-defence, with the exception of PPE intended for sporting activities; designed for private use to protect against atmospheric conditions that are not of an extreme nature and damp and water during dishwashing; for exclusive use on seagoing vessels or aircraft that are subject to the relevant international treaties applicable in Member States; for head, face or eye protection of users, that is covered by Regulation No 22 of the United Nations Economic Commission for Europe on uniform provisions concerning the approval of protective helmets and their visors for drivers and passengers of motor cycles and mopeds.
Definitions : PPE should also mean:
equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety; connexion systems for equipment that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use.
Obligations of economic operators (manufacturers, importers, distributors) :
Manufacturers and importers shall, when deemed appropriate with regard to the risks presented by PPE, carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring.
Manufacturers shall:
ensure that the PPE is accompanied by the instructions and information, as well as any labelling, shall be clear, understandable, intelligible and legible; either provide the EU declaration of conformity with the PPE or include in the instructions and information the internet address at which the EU declaration of conformity can be accessed; further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the PPE with this Regulation.
CE marking : the CE marking shall be affixed before the PPE is placed on the market . The CE marking and, where applicable, the identification number of the notified body may be followed by a pictogram or other marking indicating the risk against which the PPE is intended to protect. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.
Accreditation system : in the recitals, it is stipulated that the system set out in this Regulation should be complemented by the accreditation system provided for in Regulation (EC) No 765/2008 .
Transparent accreditation ensuring the necessary level of confidence in certificates of conformity , should be considered by the national public authorities throughout the Union as the preferred means of demonstrating the technical competence of conformity assessment bodies.
However, national authorities may consider that they possess the appropriate means of carrying out that evaluation themselves. In such cases, in order to ensure the appropriate level of credibility of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with the necessary documentary evidence demonstrating the compliance of the conformity assessment bodies evaluated with the relevant regulatory requirements
Appeal against decisions of notified bodies : notified bodies shall ensure that a transparent and accessible appeal procedure against their decisions is available.
Market surveillance : in line with the New Legislative Framework (NLF) on regulation of goods and in order to ensure legal certainty, Parliament proposed to clarify that rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to PPE covered by this Regulation. Members also introduced provisions relating to the procedure at national level for dealing with PPE presenting a risk, Union safeguard procedure as well as PPE presenting a risk for the health and safety of persons.
EP - Approval in committee of the text agreed at 1st reading interinstitutional negotiations
CSL - Coreper letter confirming interinstitutional agreement
GEDA/A/(2015)010800
The Committee on the Internal Market and Consumer Protection adopted the report by Vicky FORD (ECR, UK) on the proposal for a regulation of the European Parliament and of the Council on personal protective equipment.
The committee recommended that Parliament's position adopted at first reading following the ordinary legislative procedure should amend the Commission proposal as follows:
Purpose and scope : the Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) which is being made available on the market in order to ensure the protection of users and rules on its free movement in the Union.
Amendments aiming to include in the scope of the Regulation equipment to protect against oxygen deficiency (e.g. diving equipment), chemicals, biological agents and radiation/radioactive contamination, laser radiation and radioactive contamination, and explosive fragments are now inserted into Annex I, Category III.
designed to be used for self-defence, with the exception of PPE intended for sporting activities; intended for private use to protect against: (i) damp and water not of an extreme nature; (ii) heat, for which the economic operator does not explicitly describe and market the products as having a protective function; in the form of clothing intended for private use, with reflective or fluorescent garments which are exclusively included for reasons of design or decoration, and for which the economic operator does not describe and market the products as having a protective function; designed and placed on the market as artisanal products which are decorative in nature.
Definitions: Members wanted to see more specific technical provisions, regarding:
connection systems as items essential to the PPE's function; adding a definition of 'demonstration' and 'field test' and permitting field testing to take place. Field tests should not be designed to test the protection performance of the PPE but to evaluate other non-protective aspects such as comfort, ergonomics and design.
Obligations of economic operators (manufacturers, importers, distributors):
Manufacturers should:
keep the technical documentation and the EU declaration of conformity for at least five years after the PPE has been placed on the market (rather than 10 years as proposed by the Commission); ensure that instructions , as well as any labelling, are clear, understandable and intelligible; ensure that performance as recorded during relevant technical tests to check the levels of classes of protection provided by the PPE is available electronically or upon request.
Manufacturers should include with the EPP either the simplified EU declaration of conformity or include in the instructions or information leaflet the web site address where the EU declaration of conformity might be seen.
Importers should:
indicate, on the PPE their contact details in the official language or languages of the Member State(s) in which the PPE is to be marketed; ensure that PPE is accompanied by the instructions and safety information in a language which can be easily understood by consumers; with regard to the risks presented by PPE, carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring.
Members stressed that importers and distributors should immediately inform the manufacturer and the competent national authorities if they have reason to believe that PPE that they have placed on the market is not in conformity with the Regulation.
Examination certificate : the PPE should be examined on the basis of the latest scientific evidence. The maximum period of validity of the EU type-examination certificate should be five years and a process for reviewing the certificate should be provided. Following a positive review, a renewed certificate may continue to be valid for further periods, each of which should be for a maximum of five years.
Presumption of conformity: unless otherwise provided for by Union harmonisation legislation, the withdrawal of a harmonised standard shall not invalidate existing certificates issued by notified bodies. Products produced in accordance with the existing certificate shall still benefit from continuing conformity with the essential requirements and may continue to be placed on the market until the end of the validity of the relevant certificates issued by notified bodies.
CE marking : the CE marking and, where applicable, the identification number of the notified body may be accompanied by a pictogram or other marking indicating the risk against which the PPE is intended to protect. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.
Notification of conformity assessment bodies : accreditation should be the general rule for notified bodies. Members also stipulated that:
Member States must notify manufacturers if a notified body has ceased activity; any appeal procedure must be transparent and accessible.
Market surveillance : noting that the existing PPE legislation is in need of updating in line with the New Legislative Framework (NLF) on regulation of goods, Members introduced a new Chapter that will take into account: the requirements of the market surveillance regulation when the latter has been finalised; Union market surveillance and control of products entering the Union market; procedure applicable to PPE presenting a risk at national level, safeguard measures, etc.
Requirements for employers : Members clarified the requirements for employers who provide PPE to their employees. Accordingly, employers shall provide PPE that complies with the relevant Union provisions on design and manufacture with respect to safety and health.
EP - Committee decision to open interinstitutional negotiations with report adopted in committee
EP - AGEA Laura (EFDD) appointed as rapporteur in EMPL
EP - FORD Vicky (ECR) appointed as rapporteur in IMCO
PURPOSE: to lay down requirements for the design and manufacture of personal protective equipment (PPE) in order to ensure the health and safety protection of users and rules on its free movement in the Union.
PROPOSED ACT: Regulation of the European Parliament and the Council.
ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
BACKGROUND: Directive 89/686/EEC on personal protective equipment was adopted on 21 December 1989 and became fully applicable as from 1 July 1995. It sets out basic requirements that PPE must comply with in order to be made available on the EU market.
The PPE Directive applies to PPE that is defined as "any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards".
While the directive has successfully achieved its objectives in creating a single market and ensuring a high level of protection for users of PPE, certain problems have been encountered in its implementation. These concern products on the market that do not ensure an adequate level of protection, diverging approaches of the notified bodies, the effectiveness of the market surveillance as well as risks related to protective equipment which is currently not covered by the PPE Directive.
The proposal modifies and clarifies a number of the provisions of the existing Directive and aligns it with the provisions of Decision No 768/2008/EC establishing a common framework for the marketing of products (NLF Decision). The Commission has already proposed the alignment of nine Directives to the NLF Decision within an NLF implementation package adopted on 21 November 2011.
IMPACT ASSESSMENT: the preferred option consists of amending the PPE Directive as it: (i) lead to an improved level of protection of the health and safety of the users; (ii) ensures a more effective work of the market surveillance authorities and consequently reduces the non-compliant products; (iii) does not entail significant costs for economic operators and notified bodies.
CONTENT: this proposal intends to replace Directive 89/686/EEC on personal protective equipment by a Regulation. Its general objectives are to ensure a high level of protection of human health and safety whilst guaranteeing fair competition for economic operators on the Union market and simplifying the regulatory environment in this area.
The proposal also clarifies a number of provisions of the existing Directive and aligns it with those of the Decision No 768/2008/EC establishing a common framework for the marketing of products (decision on the new legislative framework).
Scope : the Commission proposes to enlarge the scope of the current PPE Directive by deleting the exclusions of PPE designed and manufactured for private use against heat, damp and water . The proposal keeps the other existing exclusions and clarifies that it does not apply to PPE for head, face or eye protection, subject to the relevant UNECE Regulation, of users of two- or three-wheeled motor vehicles.
Two PPE specific definitions have been added in order to clarify the applicable conformity assessment procedures: " Individually adapted PPE " and " Made-to-measure PPE ".
Making available on the market, free movement, obligations of economic operators, CE marking : the proposal:
contains the typical provisions for product-related Union harmonisation legislation and sets out the obligations of the relevant economic operators (manufacturers, authorised representatives, importers and distributors), in accordance with the NLF Decision; obliges the manufacturer of PPE to draw up a technical documentation and to ensure that the PPE is accompanied by a copy of the EU declaration of conformity or a simplified EU declaration of conformity.
Notified bodies : the proposal sets out requirements for national authorities responsible for conformity assessment bodies (notified bodies). It leaves the ultimate responsibility for designating and monitoring notified bodies with the individual Member State.
Categories and Conformity assessment : the proposal simplifies the definition of the categories of PPE. The category only depends on the risk against which the PPE is intended to protect. Provisions are set out for made-to-measure PPE. PPE intended to protect the user against drowning, cuts by hand-held chain-saws, high-pressure cutting, bullet wounds or knife stabs, and harmful noise are subject to the most stringent conformity assessment procedure .
Minor amendments have been made which change marginally three essential health and safety requirements (EHSR) in order to remove requirements shown to be impracticable or that create confusion.
Application : the proposed Regulation will become applicable two years after its entry into force to allow manufacturers, notified bodies and Member States time to adapt to the new requirements. However, the designation of notified bodies pursuant to the new requirements and process needs to start shortly after the entry into force of this Regulation.
Transitional provisions are foreseen for products manufactured and the certificates issued by notified bodies under Directive 89/686/EEC so as to allow stocks to be absorbed and ensure a smooth transition to the new requirements.
DELEGATED ACTS: this proposal contains provisions empowering the Commission to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union.
Approval in committee of the text agreed at 1st reading interinstitutional negotiations: PE610.792
Coreper letter confirming interinstitutional agreement: GEDA/A/(2015)010800
Plenary Speeches (1)
2016/11/22 Personal protective equipment (A8-0148/2015 - Vicky Ford)
Louis ALIOT
2016/11/22 Personal protective equipment (A8-0148/2015 - Vicky Ford) FR
Marina ALBIOL GUZMÁN
2016/11/22 Personal protective equipment (A8-0148/2015 - Vicky Ford) ES
Marie-Christine ARNAUTU
2016/11/22 Personal protective equipment (A8-0148/2015 - Vicky Ford) LT
Hugues BAYET
Xabier BENITO ZILUAGA
José BLANCO LÓPEZ
Louise BOURS
Marie-Christine BOUTONNET
2016/11/22 Personal protective equipment (A8-0148/2015 - Vicky Ford) IT
Gianluca BUONANNO
James CARVER
Nicola CAPUTO
Salvatore CICU
David COBURN
Alberto CIRIO
Birgit COLLIN-LANGEN
2016/11/22 Personal protective equipment (A8-0148/2015 - Vicky Ford) DE
Therese COMODINI CACHIA
Carlos COELHO
2016/11/22 Personal protective equipment (A8-0148/2015 - Vicky Ford) PT
Pál CSÁKY
2016/11/22 Personal protective equipment (A8-0148/2015 - Vicky Ford) HU
Javier COUSO PERMUY
Edward CZESAK
2016/11/22 Personal protective equipment (A8-0148/2015 - Vicky Ford) PL
Daniel DALTON
Michel DANTIN
William (The Earl of) DARTMOUTH
Rachida DATI
Isabella DE MONTE
Mireille D'ORNANO
Georgios EPITIDEIOS
2016/11/22 Personal protective equipment (A8-0148/2015 - Vicky Ford) EL
Edouard FERRAND
Doru-Claudian FRUNZULICĂ
Ildikó GÁLL-PELCZ
Francisco de Paula GAMBUS MILLET
Elena GENTILE
Arne GERICKE
Tania GONZÁLEZ PEÑAS
Takis HADJIGEORGIOU
Marian HARKIN
Mike HOOKEM
Cătălin Sorin IVAN
Marc JOULAUD
Ivan JAKOVČIĆ
2016/11/22 Personal protective equipment (A8-0148/2015 - Vicky Ford) HR
Barbara KAPPEL
Afzal KHAN
Béla KOVÁCS
Paloma LÓPEZ BERMEJO
2016/11/22 Personal protective equipment (A8-0148/2015 - Vicky Ford) SK
Ivana MALETIĆ
Andrejs MAMIKINS
2016/11/22 Personal protective equipment (A8-0148/2015 - Vicky Ford) LV
Jiří MAŠTÁLKA
2016/11/22 Personal protective equipment (A8-0148/2015 - Vicky Ford) CS
Dominique MARTIN
Notis MARIAS
Miroslav MIKOLÁŠIK
Louis MICHEL
Marlene MIZZI
Sophie MONTEL
Alessia Maria MOSCA
Renaud MUSELIER
József NAGY
Norica NICOLAI
2016/11/22 Personal protective equipment (A8-0148/2015 - Vicky Ford) RO
Franz OBERMAYR
Margot PARKER
Florian PHILIPPOT
Marijana PETIR
Andrej PLENKOVIĆ
Salvatore Domenico POGLIESE
Franck PROUST
Sofia RIBEIRO
Robert ROCHEFORT
Fernando RUAS
Lola SÁNCHEZ CALDENTEY
Olga SEHNALOVÁ
Ricardo SERRÃO SANTOS
Remo SERNAGIOTTO
Maria Lidia SENRA RODRÍGUEZ
Siôn SIMON
Branislav ŠKRIPEK
Monika SMOLKOVÁ
Igor ŠOLTES
2016/11/22 Personal protective equipment (A8-0148/2015 - Vicky Ford) SL
Davor Ivo STIER
Patricija ŠULIN
Eleftherios SYNADINOS
Claudia ȚAPARDEL
Pavel TELIČKA
Mylène TROSZCZYNSKI
Ángela VALLINA
Miguel VIEGAS
A8-0148/2015 - Vicky Ford - Résolution législative #
2016/01/20 Outcome: +: 606, -: 53, 0: 50
Albert DESS, Andreas SCHWAB, Angelika NIEBLER, Axel VOSS, Birgit COLLIN-LANGEN, Burkhard BALZ, Christian EHLER, Daniel CASPARY, David McALLISTER, Elmar BROK, Godelieve QUISTHOUDT-ROWOHL, Herbert REUL, Hermann WINKLER, Ingeborg GRÄSSLE, Jens GIESEKE, Joachim ZELLER, Karl-Heinz FLORENZ, Manfred WEBER, Markus FERBER, Michael GAHLER, Monika HOHLMEIER, Norbert LINS, Peter JAHR, Peter LIESE, Rainer WIELAND, Reimer BÖGE, Renate SOMMER, Sabine VERHEYEN, Sven SCHULZE, Thomas MANN, Werner KUHN, Werner LANGEN
Alberto CIRIO, Aldo PATRICIELLO, Alessandra MUSSOLINI, Antonio TAJANI, Barbara MATERA, Elisabetta GARDINI, Fulvio MARTUSCIELLO, Herbert DORFMANN, Lara COMI, Lorenzo CESA, Massimiliano SALINI, Salvatore CICU, Salvatore Domenico POGLIESE, Stefano MAULLU
Adam SZEJNFELD, Agnieszka KOZŁOWSKA, Andrzej GRZYB, Barbara KUDRYCKA, Bogdan Andrzej ZDROJEWSKI, Bogdan Brunon WENTA, Danuta JAZŁOWIECKA, Danuta Maria HÜBNER, Dariusz ROSATI, Elżbieta Katarzyna ŁUKACIJEWSKA, Jacek SARYUSZ-WOLSKI, Jan OLBRYCHT, Janusz LEWANDOWSKI, Jarosław KALINOWSKI, Jarosław WAŁĘSA, Jerzy BUZEK, Julia PITERA, Krzysztof HETMAN, Michał BONI, Róża THUN UND HOHENSTEIN, Tadeusz ZWIEFKA
Agustín DÍAZ DE MERA GARCÍA CONSUEGRA, Antonio LÓPEZ-ISTÚRIZ WHITE, Carlos ITURGAIZ, Esteban GONZÁLEZ PONS, Esther HERRANZ GARCÍA, Francisco José MILLÁN MON, Francisco de Paula GAMBUS MILLET, Gabriel MATO, Luis de GRANDES PASCUAL, Pablo ZALBA BIDEGAIN, Pilar AYUSO, Ramón Luis VALCÁRCEL SISO, Rosa ESTARÀS FERRAGUT, Santiago FISAS AYXELÀ, Teresa JIMÉNEZ-BECERRIL BARRIO, Verónica LOPE FONTAGNÉ
Adina-Ioana VĂLEAN, Cristian Dan PREDA, Cristian-Silviu BUŞOI, Csaba SÓGOR, Daniel BUDA, Iuliu WINKLER, Marian-Jean MARINESCU, Mihai ŢURCANU, Ramona Nicole MĂNESCU, Siegfried MUREŞAN, Theodor Dumitru STOLOJAN, Traian UNGUREANU
Alain CADEC, Alain LAMASSOURE, Angélique DELAHAYE, Anne SANDER, Arnaud DANJEAN, Brice HORTEFEUX, Constance LE GRIP, Elisabeth MORIN-CHARTIER, Franck PROUST, Françoise GROSSETÊTE, Jérôme LAVRILLEUX, Marc JOULAUD, Maurice PONGA, Michel DANTIN, Michèle ALLIOT-MARIE, Nadine MORANO, Philippe JUVIN, Rachida DATI, Renaud MUSELIER, Tokia SAÏFI
Andor DELI, Andrea BOCSKOR, András GYÜRK, György HÖLVÉNYI, György SCHÖPFLIN, Ildikó GÁLL-PELCZ, József SZÁJER, Kinga GÁL, László TŐKÉS, Norbert ERDŐS, Tamás DEUTSCH, Ádám KÓSA
Claude ROLIN, Ivo BELET, Pascal ARIMONT, Tom VANDENKENDELAERE
Carlos COELHO, Cláudia MONTEIRO DE AGUIAR, Fernando RUAS, José Manuel FERNANDES, Nuno MELO, Paulo RANGEL, Sofia RIBEIRO
Andrey KOVATCHEV, Andrey NOVAKOV, Emil RADEV, Eva MAYDELL, Mariya GABRIEL, Svetoslav Hristov MALINOV, Vladimir URUTCHEV
Jaromír ŠTĚTINA, Jiří POSPÍŠIL, Luděk NIEDERMAYER, Michaela ŠOJDROVÁ, Pavel SVOBODA, Stanislav POLČÁK, Tomáš ZDECHOVSKÝ
Anna Maria CORAZZA BILDT, Christofer FJELLNER, Gunnar HÖKMARK, Lars ADAKTUSSON
Elissavet VOZEMBERG-VRIONIDI, Georgios KYRTSOS, Manolis KEFALOGIANNIS, Maria SPYRAKI, Theodoros ZAGORAKIS
Annie SCHREIJER-PIERIK, Esther de LANGE, Jeroen LENAERS, Lambert van NISTELROOIJ, Wim van de CAMP
Anna ZÁBORSKÁ, Eduard KUKAN, Ivan ŠTEFANEC, József NAGY, Miroslav MIKOLÁŠIK, Pál CSÁKY
Claudia SCHMIDT, Elisabeth KÖSTINGER, Heinz K. BECKER, Othmar KARAS, Paul RÜBIG
Henna VIRKKUNEN, Petri SARVAMAA
Andrej PLENKOVIĆ, Davor Ivo STIER, Dubravka ŠUICA, Ivana MALETIĆ, Marijana PETIR
Algirdas SAUDARGAS, Gabrielius LANDSBERGIS
Artis PABRIKS, Inese VAIDERE, Krišjānis KARIŅŠ, Sandra KALNIETE
Alojz PETERLE, Franc BOGOVIČ, Milan ZVER, Patricija ŠULIN, Romana TOMC
Frank ENGEL, Georges BACH, Viviane REDING
Brian HAYES, Deirdre CLUNE, Mairead McGUINNESS, Seán KELLY
David CASA, Roberta METSOLA, Therese COMODINI CACHIA
Cyprus PPE
Eleni THEOCHAROUS, Lefteris CHRISTOFOROU
Bernd LANGE, Birgit SIPPEL, Constanze KREHL, Dietmar KÖSTER, Evelyne GEBHARDT, Gabriele PREUSS, Iris HOFFMANN, Ismail ERTUG, Jakob von WEIZSÄCKER, Jens GEIER, Jo LEINEN, Joachim SCHUSTER, Jutta STEINRUCK, Kerstin WESTPHAL, Knut FLECKENSTEIN, Maria NOICHL, Martina WERNER, Matthias GROOTE, Norbert NEUSER, Peter SIMON, Petra KAMMEREVERT, Susanne MELIOR, Sylvia-Yvonne KAUFMANN, Udo BULLMANN, Ulrike RODUST
Alessia Maria MOSCA, Andrea COZZOLINO, Brando BENIFEI, Cécile Kashetu KYENGE, Damiano ZOFFOLI, Daniele VIOTTI, David Maria SASSOLI, Elena GENTILE, Elly SCHLEIN, Enrico GASBARRA, Flavio ZANONATO, Gianni PITTELLA, Goffredo Maria BETTINI, Isabella DE MONTE, Luigi MORGANO, Massimo PAOLUCCI, Mercedes BRESSO, Michela GIUFFRIDA, Nicola CAPUTO, Nicola DANTI, Paolo DE CASTRO, Patrizia TOIA, Pier Antonio PANZERI, Pina PICIERNO, Renata BRIANO, Renato SORU, Roberto GUALTIERI, Silvia COSTA, Simona BONAFÈ
Adam GIEREK, Janusz ZEMKE, Lidia Joanna GERINGER DE OEDENBERG
Clara AGUILERA, Eider GARDIAZABAL RUBIAL, Enrique GUERRERO SALOM, Inma RODRÍGUEZ-PIÑERO, Inés AYALA SENDER, Iratxe GARCÍA PÉREZ, Jonás FERNÁNDEZ, José BLANCO LÓPEZ, Juan Fernando LÓPEZ AGUILAR, Ramón JÁUREGUI ATONDO, Sergio GUTIÉRREZ PRIETO, Soledad CABEZÓN RUIZ
Andi CRISTEA, Claudia ȚAPARDEL, Claudiu Ciprian TĂNĂSESCU, Cătălin Sorin IVAN, Daciana Octavia SÂRBU, Damian DRĂGHICI, Dan NICA, Doru-Claudian FRUNZULICĂ, Emilian PAVEL, Ioan Mircea PAŞCU, Maria GRAPINI, Sorin MOISĂ, Victor BOŞTINARU, Victor NEGRESCU, Viorica DĂNCILĂ
Christine REVAULT D'ALLONNES BONNEFOY, Edouard MARTIN, Emmanuel MAUREL, Eric ANDRIEU, Gilles PARGNEAUX, Guillaume BALAS, Isabelle THOMAS, Jean-Paul DENANOT, Louis-Joseph MANSCOUR, Pervenche BERÈS, Sylvie GUILLAUME, Vincent PEILLON, Virginie ROZIÈRE
Afzal KHAN, Catherine STIHLER, Clare MOODY, Claude MORAES, Dame Glenis WILLMOTT, David MARTIN, Derek VAUGHAN, Jude KIRTON-DARLING, Julie WARD, Linda McAVAN, Lucy ANDERSON, Mary HONEYBALL, Neena GILL, Paul BRANNEN, Richard CORBETT, Richard HOWITT, Seb DANCE, Sergio Gaetano COFFERATI, Siôn SIMON, Theresa GRIFFIN
Csaba MOLNÁR, István UJHELYI, Péter NIEDERMÜLLER, Tibor SZANYI
Hugues BAYET, Kathleen VAN BREMPT, Marc TARABELLA, Maria ARENA
Ana GOMES, Carlos ZORRINHO, Elisa FERREIRA, Liliana RODRIGUES, Maria João RODRIGUES, Pedro SILVA PEREIRA, Ricardo SERRÃO SANTOS
Iliana IOTOVA, Momchil NEKOV, Sergei STANISHEV
Jan KELLER, Miroslav POCHE, Olga SEHNALOVÁ, Pavel POC
Anna HEDH, Jens NILSSON, Jytte GUTELAND, Marita ULVSKOG, Olle LUDVIGSSON, Soraya POST
Eva KAILI, Giorgos GRAMMATIKAKIS, Miltiadis KYRKOS, Nikos ANDROULAKIS
Agnes JONGERIUS, Kati PIRI, Paul TANG
Boris ZALA, Monika BEŇOVÁ, Monika SMOLKOVÁ, Vladimír MAŇKA
Eugen FREUND, Evelyn REGNER, Josef WEIDENHOLZER, Karin KADENBACH, Karoline GRASWANDER-HAINZ
Christel SCHALDEMOSE, Jeppe KOFOD, Ole CHRISTENSEN
Liisa JAAKONSAARI, Miapetra KUMPULA-NATRI
Biljana BORZAN, Tonino PICULA
Vilija BLINKEVIČIŪTĖ, Zigmantas BALČYTIS
Latvia S&D
Slovenia S&D
Tanja FAJON
Marju LAURISTIN
Alfred SANT, Marlene MIZZI, Miriam DALLI
Costas MAVRIDES, Demetris PAPADAKIS
Germany ECR
Arne GERICKE, Bernd LUCKE, Hans-Olaf HENKEL, Joachim STARBATTY, Ulrike TREBESIUS
Marcus PRETZELL
Raffaele FITTO, Remo SERNAGIOTTO
Anna FOTYGA, Beata GOSIEWSKA, Bolesław G. PIECHA, Czesław HOC, Edward CZESAK, Jadwiga WIŚNIEWSKA, Janusz WOJCIECHOWSKI, Karol KARSKI, Kazimierz Michał UJAZDOWSKI, Kosma ZŁOTOWSKI, Marek JUREK, Mirosław PIOTROWSKI, Ryszard Antoni LEGUTKO, Ryszard CZARNECKI, Stanisław OŻÓG, Sławomir KŁOSOWSKI, Zbigniew KUŹMIUK, Zdzisław KRASNODĘBSKI
Romania ECR
Monica MACOVEI
Andrew LEWER, Anthea McINTYRE, Ashley FOX, Daniel DALTON, Daniel HANNAN, David CAMPBELL BANNERMAN, Emma McCLARKIN, Geoffrey VAN ORDEN, Ian DUNCAN, Jacqueline FOSTER, James NICHOLSON, Julie GIRLING, Nirj DEVA, Richard ASHWORTH, Sajjad KARIM, Syed KAMALL, Timothy Charles Ayrton TANNOCK, Timothy KIRKHOPE, Vicky FORD
Anneleen VAN BOSSUYT, Helga STEVENS, Mark DEMESMAEKER, Sander LOONES
Bulgaria ECR
Angel DZHAMBAZKI, Nikolay BAREKOV
Evžen TOŠENOVSKÝ, Jan ZAHRADIL
Greece ECR
Bas BELDER, Peter van DALEN
Slovakia ECR
Branislav ŠKRIPEK, Jana ŽITŇANSKÁ, Richard SULÍK
Denmark ECR
Anders VISTISEN, Jørn DOHRMANN, Morten MESSERSCHMIDT, Rikke-Louise KARLSSON
Finland ECR
Jussi HALLA-AHO, Pirkko RUOHONEN-LERNER
Croatia ECR
Ruža TOMAŠIĆ
Lithuania ECR
Valdemar TOMAŠEVSKI
Latvia ECR
Roberts ZĪLE
Alexander Graf LAMBSDORFF, Gesine MEISSNER, Michael THEURER, Ulrike MÜLLER
Beatriz BECERRA BASTERRECHEA, Enrique CALVET CHAMBON, Izaskun BILBAO BARANDICA, Javier NART, Maite PAGAZAURTUNDÚA, María Teresa GIMÉNEZ BARBAT, Ramon TREMOSA i BALCELLS
Mircea DIACONU, Norica NICOLAI, Renate WEBER
Dominique RIQUET, Jean ARTHUIS, Jean-Marie CAVADA, Marielle DE SARNEZ, Nathalie GRIESBECK, Robert ROCHEFORT, Sylvie GOULARD
Catherine BEARDER
Frédérique RIES, Guy VERHOFSTADT, Hilde VAUTMANS, Louis MICHEL, Philippe DE BACKER
Portugal ALDE
António MARINHO E PINTO, José Inácio FARIA
Filiz HYUSMENOVA, Ilhan KYUCHYUK, Iskra MIHAYLOVA, Nedzhmi ALI
Czechia ALDE
Dita CHARANZOVÁ, Martina DLABAJOVÁ, Pavel TELIČKA, Petr JEŽEK
Cecilia WIKSTRÖM, Fredrick FEDERLEY, Jasenko SELIMOVIC
Cora van NIEUWENHUIZEN, Gerben-Jan GERBRANDY, Jan HUITEMA, Johannes Cornelis van BAALEN, Marietje SCHAAKE, Sophia IN 'T VELD
Jens ROHDE, Morten PETERSEN, Ulla TØRNÆS
Anneli JÄÄTTEENMÄKI, Hannu TAKKULA, Nils TORVALDS, Paavo VÄYRYNEN
Croatia ALDE
Ivan JAKOVČIĆ, Jozo RADOŠ
Petras AUŠTREVIČIUS, Valentinas MAZURONIS
Iveta GRIGULE-PĒTERSE
Charles GOERENS
Kaja KALLAS, Urmas PAET, Yana TOOM
Barbara LOCHBIHLER, Helga TRÜPEL, Jan Philipp ALBRECHT, Julia REDA, Klaus BUCHNER, Maria HEUBUCH, Martin HÄUSLING, Rebecca HARMS, Reinhard BÜTIKOFER, Ska KELLER, Sven GIEGOLD, Terry REINTKE
Ernest MARAGALL, Ernest URTASUN, Jordi Vicent SEBASTIA TALAVERA, Josep-Maria TERRICABRAS
José BOVÉ, Karima DELLI, Michèle RIVASI, Pascal DURAND, Yannick JADOT
Alyn SMITH, Ian HUDGHTON, Jean LAMBERT, Jill EVANS, Keith TAYLOR, Molly SCOTT CATO
Hungary Verts/ALE
Benedek JÁVOR, Tamás MESZERICS
Bart STAES, Philippe LAMBERTS
Bodil VALERO, Max ANDERSSON, Peter ERIKSSON
Bas EICKHOUT, Judith SARGENTINI
Michel REIMON, Monika VANA, Ulrike LUNACEK
Heidi HAUTALA
Lithuania Verts/ALE
Bronis ROPĖ
Slovenia Verts/ALE
Cornelia ERNST, Fabio DE MASI, Gabriele ZIMMER, Helmut SCHOLZ, Stefan ECK
Barbara SPINELLI, Curzio MALTESE, Eleonora FORENZA
Abstain (11)
Estefanía TORRES MARTÍNEZ, Javier COUSO PERMUY, Josu JUARISTI ABAUNZ, Lola SÁNCHEZ CALDENTEY, Maria Lidia SENRA RODRÍGUEZ, Marina ALBIOL GUZMÁN, Miguel URBÁN CRESPO, Paloma LÓPEZ BERMEJO, Tania GONZÁLEZ PEÑAS, Xabier BENITO ZILUAGA, Ángela VALLINA
Marie-Christine VERGIAT, Patrick LE HYARIC, Younous OMARJEE
Inês Cristina ZUBER, João FERREIRA, Miguel VIEGAS
Jiří MAŠTÁLKA, Miloslav RANSDORF
Malin BJÖRK
Dimitrios PAPADIMOULIS, Kostadinka KUNEVA, Kostas CHRYSOGONOS, Sofia SAKORAFA, Stelios KOULOGLOU
Anja HAZEKAMP, Anne-Marie MINEUR, Dennis de JONG
Merja KYLLÖNEN
Luke Ming FLANAGAN, Lynn BOYLAN, Matt CARTHY
Neoklis SYLIKIOTIS, Takis HADJIGEORGIOU
Germany NI
Martin SONNEBORN, Udo VOIGT
Janusz KORWIN-MIKKE
Aymeric CHAUPRADE
Bruno GOLLNISCH, Jean-Marie LE PEN
Diane DODDS
Béla KOVÁCS, Zoltán BALCZÓ
Greece NI
Eleftherios SYNADINOS, Georgios EPITIDEIOS, Lampros FOUNTOULIS
Kostas PAPADAKIS, Sotirios ZARIANOPOULOS
Italy EFDD
Daniela AIUTO, Dario TAMBURRANO, David BORRELLI, Eleonora EVI, Fabio Massimo CASTALDO, Giulia MOI, Ignazio CORRAO, Isabella ADINOLFI, Laura AGEA, Laura FERRARA, Marco AFFRONTE, Marco VALLI, Marco ZANNI, Marco ZULLO, Piernicola PEDICINI, Rosa D'AMATO, Tiziana BEGHIN
Poland EFDD
Robert Jarosław IWASZKIEWICZ
France EFDD
Joëlle BERGERON
United Kingdom EFDD
Bill ETHERIDGE, David COBURN, Diane JAMES, Gerard BATTEN, James CARVER, Jane COLLINS, Jill SEYMOUR, John Stuart AGNEW, Jonathan ARNOTT, Julia REID, Louise BOURS, Margot PARKER, Mike HOOKEM, Nathan GILL, Nigel FARAGE, Patrick O'FLYNN, Paul NUTTALL, Raymond FINCH, Roger HELMER, Steven WOOLFE, Tim AKER, William (The Earl of) DARTMOUTH
Czechia EFDD
Petr MACH
Sweden EFDD
Kristina WINBERG, Peter LUNDGREN
ENF
Italy ENF
Gianluca BUONANNO, Lorenzo FONTANA, Mara BIZZOTTO, Mario BORGHEZIO, Matteo SALVINI
Poland ENF
Michał MARUSIK
Romania ENF
Laurenţiu REBEGA
France ENF
Bernard MONOT, Dominique BILDE, Dominique MARTIN, Edouard FERRAND, Florian PHILIPPOT, Gilles LEBRETON, Jean-François JALKH, Jean-Luc SCHAFFHAUSER, Joëlle MÉLIN, Louis ALIOT, Marie-Christine ARNAUTU, Marie-Christine BOUTONNET, Marine LE PEN, Mireille D'ORNANO, Mylène TROSZCZYNSKI, Philippe LOISEAU, Sophie MONTEL, Steeve BRIOIS, Sylvie GODDYN
United Kingdom ENF
Belgium ENF
Gerolf ANNEMANS
Netherlands ENF
Auke ZIJLSTRA, Marcel de GRAAFF, Olaf STUGER, Vicky MAEIJER
Austria ENF
Barbara KAPPEL, Franz OBERMAYR, Harald VILIMSKY
209 2014/0108(COD)
2015/03/03 IMCO 92 amendments...
Amendment 147 #
(9) Some products on the market that provide a protective function to the user are excluded from the scope of Directive 89/686/EEC. In order to ensure as high level of protection for the user of those products as for the PPE covered by Directive 89/686/EEC, the scope of this Regulation should include PPE for private use against damp, water and heat (e.g. dish-washing gloves, oven gloves), in line with similar PPE for professional use which is already covered by Directive 89/686/EEConly if they are supposed to be understood as potentially life-saving by the consumer, or products intended to be used by children. Artisanal products, such as handmade gloves, for which the manufacturer does not explicitly claim a protective function are not personal protective equipment either; they are therefore not concerned by this inclusion. It is also appropriate to clarify the exclusion list set out in Annex I to Directive 89/686/EEC by adding a reference to products covered by other legislation and/or European harmonised standards and therefore are excluded from the PPE Regulation.
Pascal ARIMONT, Andreas SCHWAB
(9) Some products on the market that provide a protective function to the user are excluded from the scope of Directive 89/686/EEC. In order to ensure as high level of protection for the user of those products as for the PPE covered by Directive 89/686/EEC, the scope of this Regulation should include PPEproducts for private use against damp, water and heat (e.g. dish-washing gloves, oven gloves), in line with similar PPE for professional use which is already covered by Directive 89/686/EEC. Artisanal products, such as hto protect against heat, as well as products with reflective or fluorescent components, the main functions of which are protective and which are explicitly described and made gloves, for whichrketed accordingly by their manufacturer does not explicitly claim a protective function are not personal protective equipment; they are therefore not concerned by this inclusion. It is also appropriate to clarify the exclusion list set out in Annex I to Directive 89/686/EEC by adding a reference to products covered by other legislation and therefore are excluded from the PPEs. Products of a decorative nature or for private use to protect against harmless atmospheric conditions, damp, water or cleaning materials of weak action are not PPE and should not therefore fall within the scope of the Regulation.
Kerstin WESTPHAL
(For the definition of 'sport' see footnote no 2 to the Commission's 2007 white paper on(9a) Equipment in the form of clothing made from bright, shiny, reflective or fluorescent materials, which is designated by its manufacturer for sports use, is recognised by its users as being for sport and is used only in that context, should not be included in the list of PPE in Annex II, point 2.13, because it is intended primarily not to protect against risks within the meaning of Article 3(1)(a) in association with Annex I but merely to assist its users in practising their sport. (The author of this amendment has decided, following talks with the Federation of the European Sporting Goods Industry (FESI) and Nike, to insert her own explanatory justification here.) Or. de sport.)
Vicky FORD, Robert ROCHEFORT
(9a) Products intended for private use to protect against atmospheric conditions that are not of an extreme nature should include items such as seasonal clothing and umbrellas. Products intended for private use to protect against damp and water should include items such as dishwashing gloves. Products intended for private use to protect against heat, for which the economic operator does not claim a protective function, should include items such as decorative oven gloves.
Pascal ARIMONT
(14) It is necessary to ensure that PPE entering the Union market complies with this Regulation and, in particular, that appropriate conformity assessment procedures have been carried out by manufacturers. Provision should therefore be made for importers to make sure that the PPE theyto the effect that importers shall place on the market only PPE which complies with the requirements of this Regulation and that they do not place on the market PPE which does not comply with such requirements or whichdoes not present a risk. Provision should also be made for importers to make sure that the conformity assessment procedures have been carried out and that the CE marking and technical documentation drawn up by manufacturers are available for inspection by the market surveillance authorities.
(14) It is necessary to ensure that PPE entering the Union market complies with this Regulation, with European harmonised standards and, in particular, that appropriate assessment procedures have been carried out by manufacturers. Provision should therefore be made for importers to make sure that the PPE they place on the market complies with the requirements of this Regulation and that they do not place on the market PPE which does not comply with such requirements or which present a risk. Provision should also be made for importers to make sure that the conformity assessment procedures have been carried out and that the CE marking and technical documentation drawn up by manufacturers are available for inspection by the market surveillance authorities.
(16) When placing PPE on the market, importers should indicate on the product their name and the address at which they can be contacted. Exceptions should be provided for in cases where the size or nature of the PPE does not allow for such an indication. This includes cases where the importer would have to open the packaging to put his name and address on the productor its cover their e-mail address at which they can be contacted.
(20a) 'Field test' means a trial period by the user of non-compliant PPE, before it is placed on market and for which all the necessary information of tests carried out by accredited or authorised laboratories is available in the technical file to ensure the protection of the user and meets the applicable requirements in Annex II, is made available in a very limited number for a limited time and whose principal purpose is to undertake a final evaluation of its non-protection characteristics.
(22) The requirement in other internal market legislation to supply an EU declaration of conformity with the equipment has been found to facilitate and to enhance the efficiency of market surveillance and should therefore also be introduced into this Regulation. It should be possible to provide a simplified EU declaration of conformity in order to reduce the burden associated with this requirement without reduction of its effectiveness. Both possibilities should therefore be provided for in this RegulationMarket surveillance authorities should have easy access to the declaration of conformity. In order to fulfil that requirement, manufacturers should ensure the PPE is accompanied by a full copy of the declaration of conformity and the internet address at which the EU declaration of conformity can be accessed. The manufacturer should also be able to choose to provide a simplified declaration of conformity.
(23) In order to increase the efficiency of market surveillance it is necessary to extend the obligation to draw up a complete technical documentation to all PPE characterised as having a "protective function".
(24) In order to ensure that PPE isPPE should be examined on the basis of the state of the art the limit. The minimum period of validity of the EU type- examination certificate should set to a maximum ofbe five years. A and a process for reviewing the certificate should be provided for. A minimum content of the certificate should be required in order to facilitate the work of the market surveillance authorities.
(24) In order to ensure that PPE is examined on the basis of the state of the art and to boost consumer confidence, the limit of validity of the EU type- examination certificate should set to a maximum of five10 years. A process for reviewing the certificate should be provided for. A minimum content of the certificate should be required in order to facilitate the work of the market surveillance authorities.
(24a) The withdrawal of a harmonised standard should not invalidate existing certificates issued by notified bodies; it only concerns the conformity that is conferred onto new conformity assessments that follow the new harmonised standard. Products produced in accordance with the existing certificate should still benefit from the continuing conformity with the essential requirements and it should continue to be possible to place them on the market until the end of the validity of the relevant certificates issued by notified bodies.
Recital 24 b (new)
(24b) In order to ensure that the review process takes place without placing an unnecessary burden on manufacturers, a simplified procedure should be applied for re-certification of the EU type examination certificate when the product, applied harmonised standards or other technical solutions applied by the manufacturer have not been changed and continue to meet the essential health and safety requirements in the light of the state of the art, making therefore unnecessary additional tests or technical examinations.
(27) The CE marking should be the only marking indicating that PPE is in conformity with Union harmonisation legislation. However, other markings should be allowed as long as they contribute to the improvement of consumer protection, particularly with regard to transparency and to explaining the certification, and are not covered by Union harmonisation legislation.
(27) The CE marking should be the only marking indicating that PPE is in conformity with Union harmonisation legislation. However, other markings should be allowed as long as they contribute to the improvement of consumer protection and are not covered by Union harmonisation legislationin accordance with European harmonised standards.
(30) In order to ensure a consistent level of quality in the performance of conformity assessment of PPE, it is also necessary to set requirements that notifying authorities and other bodies involved in the assessment, notification and monitoring of notified bodies must fulfil and to delimit their responsibilities clearly.
(31) In order to take into account the progress of technical knowledge and new scientific evidence, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission to amend the list of PPE included in each categorycategories of risk against which the PPE is intended to protect users and consumers, and to draw up a non-exhaustive list of products used in private households, which are not covered by this Regulation. It is of particular importance that the Commission carriesy out appropriate and transparent consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.
(33) Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive. The Member States' efficient application of the penalties will be decisive with regard to their effectiveness and also of key importance in terms of the overall value of the Regulation.
The provisions of this Regulation are based on the precautionary principle. Or. de (In accordance with Article 191(2) of the TFEU)
Article 2 – paragraph 2 – point b
(b) intenddesigned to be used for self-defence, other than PPE intended for self-defence in sporting activities;
(c) intended for private use to protect against harmless atmospheric conditions that are not of an extreme nature;
Article 2 – paragraph 2 – point c – point i (new)
(i) atmospheric conditions that are not of an extreme nature (including, but not limited to, seasonal clothing and umbrellas);
(i) heat (gloves etc.) for which the economic operator does not explicitly claim a protective function against short- term exposure to dangerous heat;
Article 2 – paragraph 2 – point c – point ii (new)
(ii) damp and water not of an extreme nature (including, but not limited to, dish- washing gloves);
Article 2 – paragraph 2 – point c – point iii (new)
(iii) heat (including, but not limited to, gloves) for which the economic operator does not explicitly claim a protective function against extreme heat;
Article 2 – paragraph 2 – point c a (new)
(ca) intended for protection, in private households, against damp, water or cleaning materials of weak action;
Article 2 – paragraph 2 – point c b (new)
(cb) intended for protection, in private households, against heat, and not explicitly described and marketed by their manufacturer as having this protective function;
Article 2 – paragraph 2 – point c c (new)
(cc) intended for private use and decorative in nature or containing reflective or fluorescent elements and not specifically designated or advertised by the manufacture as having a protective function;
Article 2 – paragraph 1 – point e a (new)
(ea) in the form of clothing, with reflective or fluorescent garments that do not completely encircle a part of the body (arm, leg or chest) and for which the economic operator does not explicitly claim a protective function against one or more risks to the user´s health or safety;
(ea) in the form of clothing, with reflective or fluorescent garments that do not completely encircle a part of the body (arm, leg, or chest), which are included for reasons of fashion and for which the economic operator does not explicitly claim a protective function against one or more risks to the user's health or safety;
Article 3 – paragraph 1 – point 1 – point a
(a) equipment intended to be worn or held by a person for protection against one or more risks for his or her health or safety and therefore marked as having a "protective function", that is placed on the market separately or combined with personal non-protective equipment;
Article 3 – paragraph 1 – point 1 – point c
(c) connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are intenddesigned to connect that equipment to an external device or structure, that are removable and not intended to be permanently fixed to a structurto a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use;
Article 3 – paragraph 1 – point 2
2. 'individually adapted PPE' means PPE produced in series where each item is, after manufactured to fit an for its intended purpose, can be adapted to the needs of individual users;
Article 3 – paragraph 1 – point 3 a (new)
3a.'PPE type ': sample of complete PPE used as a model for a PPE series that is described in the technical documentation in accordance with Annex III and has - in the case of category II or III - undergone the EU type-examination procedure in accordance with Annex I;
Article 7 – paragraph 2 – subparagraph 1
At trade fairs, exhibitions, and demonstrations or field tests, Member States shall not prevent the showing of PPE which does not comply with this Regulation provided that a visible sign clearly indicates that the PPEand is not available on the market. Field tests shall not be does not comply with this Regulation and is not availabligned to test the protection performance of the PPE, but to evaluate on the market until it has been brought intor non-protective aspects such as conmformityt, ergonomics and design.
3. Manufacturers shall keep the technical documentation and the EU declaration of conformity for at least 10five years after the PPE has been placed on the market.
4. Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Regulation. Changes in the design or characteristics of the PPE and changes in the harmonised standards or in other technical specifications by reference to which the conformity of the PPE is declared shall be adequately taken into account. and accordingly attest it by the EU declaration of conformity. 4a. Changes in the harmonised standards or in other technical specifications as regards the EHSR and changes in Annexes I or II to this Regulation shall be adequately taken into account by either repeating or updating or integrating the conformity assessment procedures as provided for in Article 18. 4b. Changes in the harmonised standards or in other technical specifications not in relation with the EHSR shall be adequately taken into account by the manufacturers, which may decide to either repeat, update or integrate the conformity assessment procedures as provided for in Article 18. 4c. Changes by the manufacturer in the design or characteristics of the PPE that affect the compliance with EHSR shall be adequately taken into account by either repeating or updating or integrating the conformity assessment procedures as provided for in Article 18. 4d. With regard to PPE of categories II and III, manufacturers that intend to change the design or characteristics of the PPE without impact to the compliance with EHSR shall inform and obtain authorisation from the notified body.
5. Manufacturers shall ensure that the PPE which they place on the market bears either a type, batch or serial number or other element allowing its identification or, where the size or nature of the PPE does not allow it, that the required information is provided on the packaging or a document accompanying the PPE.
6. Manufacturers shall indicate, on the PPE, their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the PPE. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in athe language easily understood by end-users and market surveillance authoritiesor languages of the Member State in which the product is to be marketed.
6. Manufacturers shall indicate, on the PPE, their name, registered trade name or registered trade mark and, the postal or e-mail address at which they can be contacted or, where that is not possible, onn the PPE, its packaging or in a document accompanying the PPE. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by end-users and market surveillance authorities.
6. Manufacturers shall indicate, on the PPE, their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the PPE. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by end-users and market surveillance authoritiesthe official language or languages of the Member States(s) in which the PPE is to be marketed.
7. Manufacturers shall ensure that the PPE is accompanied by the instructions set out in point 1.4 of Annex II in a language which can be easily understood by end-users, as determined by the Member State concerned.deleted
Article 8 – paragraph 7 – subparagraph 1 a (new)
Manufacturers shall have the possibility to provide manufacturers´ instructions, labelling or marking by pictograms on the PPE or, where the size or nature of the PPE does not allow it, on the packaging or a document accompanying the PPE.
7a. Manufacturers shall ensure that performance as recorded during relevant technical tests to check the levels of classes of protection provided by the PPE is available electronically or upon request.
9. Manufacturers who consider or have reason to believe that PPE which they have placed on the market is not in conformity with this Regulation shall immediately take the necessary corrective measures to bring it into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, manufacturers shall immediately inform the market surveillance authorities of the Member States in which they made the PPE available on the market and, where necessary, in a suitable manner, consumers who might be endangered by the product non-conformity to that effect, giving details, in particular, of the non- conformity and of any corrective measures taken.
Article 8 – paragraph 10
10. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the PPE, in paper or electronic form, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have placed on the market.
10. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the PPE, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have placed on the market.
Article 10 – paragraph 3
3. Importers shall indicate, on the PPE, their name, registered trade name or registered trade mark and the posta their name, postal or e-mail address at which they can be contacted, or where that is not possible, onn the PPE, its packaging or in a document accompanying the PPE. Importers shall indicate the registered trade name or registered trade mark if different from that of the manufacturer . The contact details shall be in a language easily understood by end-users and market surveillance authorities.
3. Importers shall indicate, on the PPE, their name, registered trade name or registered trade mark and the postal address at which they can be contacted, or where that is not possible, on its packaging or in a document accompanying the PPE. The contact details shall be in a language easily understood by end-users and market surveillance authoritiesthe official language or languages of the Member State(s) in which the PPE is to be marketed.
6. Importers who consider or have reason to believe that PPE which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring the PPE into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, importers shall immediately inform the market surveillance authorities of the Member States in which they made the PPE available on the market and, where necessary, in a suitable manner, consumers who might be endangered by the product non-conformity to that effect, giving details, in particular, of the non- conformity and of any corrective measures taken.
7. Importers shall, for at least 10 years after the PPE has been placed on the market, keepensure that a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that nd the technical documentation can be made available to those market surveillance authorities, upon request.
7. Importers shall, for at least 10 years after the PPE has been placed on the market, keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request. After five years, it shall be sufficient to keep a declaration of conformity in electronic form.
8. Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of PPE in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have placed on the market.
Article 11 – paragraph 2 – subparagraph 1
Before making PPE available on the market, distributors shall verify that it bears the CE marking, is accompanied by the EU declaration of conformity or a simplified EU declaration of conformity, and that it is accompanied by the instructions set out in point 1.4 of Annex II in a language which can be easily understood byrequired documents in an official language of the EU representing end- users in the Member State in which PPE is to be made available on the market and that the manufacturer and the importer have complied with the requirements set out in Article 8(5) and (6) and Article 10(3).
4. Distributors who consider or have reason to believe that PPE which they have made available on the market is not in conformity with the requirements of this Regulation shall make sure that the necessary corrective measures are taken to bring it into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, distributors shall immediately inform the market surveillance authorities of the Member States in which they have made the PPE available on the market and, if necessary, and in an appropriate manner, the consumers who could be placed at risk by virtue of the non-conformity of the product, to that effect, giving details, in particular, of the non- conformity and of any corrective measures taken.
5. Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the PPE. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have made available on the market.
Article 14 – paragraph 1 a (new)
Unless otherwise provided for by legislation, the withdrawal of a harmonised standard shall not invalidate existing certificates issued by notified bodies, it shall only concern the conformity that is conferred onto new conformity assessments that follow the new harmonised standard. Products produced in accordance with the existing certificate shall still benefit from continuing conformity with the essential requirements and may continue to be placed on the market until the end of the validity of the relevant certificates issued by notified bodies.
4. For category III PPE, the CE marking shall be followed by the identification number of the notified body involved in the procedure for ensuring conformity to type based on product verification or the procedure for ensuring conformity to type based on quality assurance of the production process. The identification number of the notified body shall be affixed by the manufacturer or his authorised representative after having received permission and instructions from the notified body to do so.
4. For category III PPE, the CE marking shall be followed by the identification number of the notified body involved in the procedure for ensuring conformity to type based on product verification or the procedure for ensuring conformity to type based on quality assurance of the production process. The identification number of the notified body shall be affixed under its instructions, by the manufacturer or his authorised representative.
Article 23 – paragraph 11
11. Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under Article 35 of this Regulation and shall apply as general guidance the administrativthe decisions and documents produced as a result of the work of that group.
2. The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment procedure(s) and the kinds of PPE for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 23.
3. Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 23.deleted
4. Where a notification is not based on an accreditation certificate referred to in Article 26(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment body's competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 23.deleted
Member States shall ensure that an EU- wide appeal procedure against decisions of the notified bodies is available.
Member States shall ensure that the bodies notified by themNotified bodies shall participate in the work of that group, directly or by means of designated representatives. In the event that a notified body does not comply with this requirement, the notification shall be suspended or withdrawn.
The Commission shall be empowered to adopt, in response to technical progress and new knowledge or scientific evidence, delegated acts in accordance with Article 37 on the drawing-up of a non-exhaustive list of products covered by Article 2(2)(c) to (cc) inclusive.
Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by [3 months prior to the date of application of this Regulation] at the latest and shall notify it without delay of any subsequent amendment affecting themThey must also reflect the seriousness, the duration and, if possible, the nature of the infringement and the issue of whether or not the economic operator in question has perpetrated a similar infringement in the recent past. Member States shall notify those provisions to the Commission by [3 months prior to the date of application of this Regulation] at the latest and shall notify it without delay of any subsequent amendment affecting them. Member States shall notify the Commission of the nature and severity of the penalties imposed under this Regulation on their territory and of the identity of the recipient of each penalty. The Commission shall publish this notification immediately.
Annex I – section 1 – paragraph 1 – point b
(b) contact with water or cleaning materials of weak action;deleted
(b) contact with water or cleaning materials of weak action or prolonged contact with water;
(b) made-to-measure PPE except where such PPE is intended to protect users against risks listed in Category I.deleted
Annex I – section 3 – paragraph 1 – point a
(a) inhalation of harmful substanchealth hazardous substances, chemicals and mixtures;
(b) aggressive chemicalharmful biological agents;
Annex I – section 3 – paragraph 1 – point l a (new)
(la) occupational risk of severe impact to the head.
Annex II – part 1 – point 1.3 – point 1.3.3 – paragraph 1
If the same manufacturer places on the market several models of PPE models of different types in order to ensure the simultaneous protection of adjacent parts of the body, they must be compatible.
Annex II – part 1 – point 1.3 – point 1.3.3 a (new)
1.3.3 a. Protective clothing containing removable protectors Protective clothing containing removable protectors constitute PPE and should be assessed as a combination during conformity assessment procedures.
Annex II – part 1 – point 1.4 – introductory part
1.4. Manufacturer's instructions and information
Annex II – part 1 – point 1.4 – paragraph 1 – point b
(b) performance as recorded during technical tests to check the levels or classes of protection provided by the PPE;deleted
Annex II – part 1 – point 1.4 – paragraph 1 – subparagraph 1
These instructions, which must be precise and comprehensible and clearly legible, must be provided at least in the official language(s) of the Member State of destination. The instructions shall be deemed to be clearly legible if they can be read easily from an appropriate distance and without artificial aids by a normal user with normal vision.
Annex II – part 2 – point 2.2 – paragraph 1
As far as possible, PPE enclosing the parts of the body to be protected must be sufficiently ventilatdesigned to limit perspiration resulting from use; otherwise, it must be equipped with means of absorbing perspiration must be incorporated.
Where PPE incorporates components which can be adjusted or removed by the user for replacement purposes, they must be designed and manufactured so that they can be easily attached, adjusted and removed without tools.
Annex II – part 2 – point 2.12 – paragraph 1
The identification markings or indicators directly or indirectly relating to health and safety affixed to these types of PPE must, if possible, take the form of harmonized pictograms or ideograms. They must be perfectly visible and legible and remain so throughout the foreseeable useful life of the PPE. In addition, these markings must be complete, precise and comprehensible so as to prevent any misinterpretation; in particular, when such markings include words or sentences, the latter must be written in the official language(s) of the Member State where the equipment is to be used.of destination of the PPE;
The identification markings or indicators directly or indirectly relating to health and safety affixed to these types of PPE must, if possible, take the form of harmonized pictograms or ideograms. They must be perfectly visible and legible and remain so throughout the foreseeable useful life of the PPE. In addition, these markings must be complete, precise and comprehensible so as to prevent any misinterpretation; in particular, when such markings include words or sentences, the latter must be written in the official language(s) of the Member State where theon whose market the individual equipment is to be usedoffered for sale.
Annex II – part 3 – point 3.4 – title
3.4. Protection in the waterliquids
Clothing which will ensure an effective degree of buoyancy, depending on its foreseeable use, which is safe when worn and which affords positive support in waterliquids. In foreseeable conditions of use, this PPE must not restrict the user's freedom of movement but must enable him, in particular, to swim or take action to escape from danger or to rescue other persons.
Annex V – section 1 – point 6 – point 6.2 – point i
(i) the date of issue and, where appropriate, the date of expiry or the date(s) of renewal;
Annex V – section 1 – point 6 – point 6.2 – point j
(j) the date of expiry (a maximum of five years after the date of issue or the date of the last renewal);deleted
(j) the date of expiry (a maximum of five years after the date of issue or the date of the last renewal) where appropriate;
Annex V – section 1 – point 7 – point 7.1 a (new)
7.1a. At the earliest five years after the date of issue or the last date of renewal, and if changes to the acknowledged state of the art suggest that the approved type no longer meets key health and safety requirements, the notified body shall decide whether the type in question should undergo a fresh EU type-approval procedure.
7.6.a When the product, harmonised standards or other technical solutions applied by the manufacturer have not been changed and continue to meet the essential health and safety requirements, in light of the state of the art standards, a simplified procedure shall be applied for automatic re-certification therefore making additional tests or technical examinations unnecessary.
source: 549.462
2015/03/04 EMPL 117 amendments...
Terry REINTKE, Karima DELLI
Recital -1 (new)
(-1) The right to health and safety is a fundamental right and all workers enjoy a legal guarantee of working conditions which respect their health, safety and dignity. Considering that the cost to enterprises and social security systems of occupational accidents and diseases is estimated at 5,9 % of GDP and that adequate worker prevention promotes wellbeing, quality of work and productivity, risk prevention, in particular through the use of quality personal protective equipment, is essential to reducing the rate of work-related accidents and sickness.
(3) However, experience with its application has shown inadequacies and inconsistencies in the product coverage and conformity assessment procedures. In order to take account of this experience and to provide clarification in relation to the framework within which products covered by this Regulation may be marketed, certain aspects of Directive 89/686/EEC should be revised and enhanced while maintaining the overarching principle of health and safety protection.
Guillaume BALAS
(3a) This Regulation should apply to all forms of supply, including distance selling.
(4) Since the scope, the essential health and safety requirements and conformity assessment procedures are to be identical in all the Member States there is almost no flexibility in transposing Directives based on the New Approach principles into national law. Directive 89/686/EEC should therefore be replaced by a Regulation, which is the appropriate legal instrument for imposing clear and detailed rules which do not give room for divergent transposition by Member States. with a view, in particular, to safeguarding public health, improving safety at work, and ensuring user protection.
Ulla TØRNÆS
(4) Since the scope, the essential health and safety requirements and conformity assessment procedures are to be identical in all the Member States there is almost no flexibility in transposing Directives based on the New Approach principles into national law. Directive 89/686/EEC should therefore be replaced by a Regulation, which is the appropriate legal instrument for imposing clear and detailed rules which do not give room for divergent transposition by Member States this should be done by applying a clear and target- based approach with the aim of improving safety at work and ensuring user protection.
Anthea McINTYRE
(9) Some products on the market that provide a protective function to the user are excluded from the scope of Directive 89/686/EEC where they are only intended for private use. In order to ensurprovide as high level of protection for the user of those products as for the PPE covered by Directive 89/686/EEC, the scope of this Regulation, items for protecting the hands against extreme heat in a domestic environment should be include PPE for private use against damp, water and heat (e.g. dish-washing gloves, oven gloves), in line with similar PPE for professional use which is already covered by Directive 89/686/EECd within the scope of this Regulation if they specifically make a protective claim. Artisanal products, such as handmade gloves and oven gloves, for which the manufacturer does not explicitly claim a protective function are not personal protective equipment; they areshould therefore not concerned by this inclusion. It is also appropriate to clarify the exclusion list set out in Annex I to Directive 89/686/EEC by adding a reference to products covered by other legislation and therefore are excluded from the PPE Regulationbe included in the scope of this Regulation. Instead, self-certification should be encouraged for those products. Many manufacturers are already doing this today.
(9) Some products on the market that provide a protective function to the user are excluded from the scope of Directive 89/686/EEC. Any such exclusion should only be allowed if an equivalent level of health and safety protection to this Regulation or Directive 89/3921/EC is provided for. In order to ensure as high level of protection for the user of those products as for the PPE covered by Directive 89/686/EEC, the scope of this Regulation should include PPE for private use against damp, water and heat (e.g. dish-washing gloves, oven gloves), in line with similar PPE for professional use which is already covered by Directive 89/686/EEC. Artisanal products, such as handmade gloves, for which the manufacturer does not explicitly claim a protective function are not personal protective equipment; they are therefore not concerned by this inclusion. It is also appropriate to clarify the exclusion list set out in Annex I to Directive 89/686/EEC by adding a reference to products covered by other legislation and therefore are excluded from the PPE Regulation.
(10) In order to facilitate the understanding and uniform application of this Regulation, new definitions for 'individually adapted PPE' and 'made-to- measure PPE' should be introduced and the conformity assessment procedures for these kinds of PPE should be adapted to the specific conditions of their manufacture.deleted
(10) In order to facilitate the understanding and uniform application of this Regulation, new definitions for 'individually adapted PPE' and 'made-to-measure PPE' should be introduced including clear definitions of the end-user of PPE and the conformity assessment procedures for these kinds of PPE should be adapted to the specific conditions of their manufacture. In the definition of "individually adapted PPE" and "made-to-measure PE" it should be clearly stated that the individualisation of PPE must have a material impact on the working environment and safety at work.
(10a) During field demonstrations and field tests, adequate measures should be taken to ensure the protection of persons. Field tests should not be designed to test the protection performance of the PPE but to evaluate other non-protective aspects such as comfort, ergonomics and design. All concerned parties, for instance the employer as well as the wearer or the consumer, should be informed in advance concerning the scope and purpose of the test.
(11) Economic operators should be responsible for the compliance of products, in relation to their respective roles in the whole supply chain, so as to ensure a high level of protection of public interests, such as health and safety, and the proper information and protection of users and to guarantee fair competition on the Union market.
(11) Economic operators should be responsible for the compliance of productsthe PPE, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of public interests, such as health and safety, and the protection of users and, where appropriate, other persons, to guarantee fair competition on the Union market.
(11) Economic operators should be responsible for the compliance of productsPPE, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of public interests, such as health and safety, and the protection of users and to guarantee fair competition on the Union market.
(12) All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that PPE protects the health and safety of persons and that they make available on the market only products which complPPE which is in conformity with this Regulation. This Regulation should provide a clear and proportionate distribution of obligations which correspond to the role of each economic operator in the supply and distribution chain.
(12) All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that PPE protects the health and safety of persons and that they make available on the market only productsPPE which complyies with this Regulation. This Regulation should provide a clear and proportionate distribution of obligations which correspond to the role of each operator in the supply and distribution chain.
(12a) In order to facilitate communication between economic operators, market surveillance authorities and consumers, Member States should encourage economic operators to include a website address in addition to the postal address.
(14) It is necessary to ensure that PPE entering the Union market complies with this Regulation and, in particular, that appropriate assessment procedures have been carried out by manufacturers. Provision should therefore be made for importers to make sure that the PPE they place on the market complies with the requirements of this Regulation and that they do not place on the market PPE which does not comply with such requirements or which present a risk. Provision should also be made for importers to make sure that the conformity assessment procedures have been carried out and that the CE marking and technical documentation drawn up by manufacturers are available for inspection by the markecompetent surveillance authorities.
(16) When placing PPE on the market, importers should indicate on the product their name and the address at which they can be contacted as well as indications of webpages on which the end-user of the PPE can access additional information on how to correctly use the PPE. Exceptions should be provided for in cases where the size or nature of the PPE does not allow for such an indication. This includes cases where the importer would have to open the packaging to put his name and address on the product.
(17) Any economic operator that either places PPE on the market under its own name or trademark or modifies a product in such a way that compliance with the requirements of this Regulation may be affected ishould be considered to be the manufacturer and should assume the obligations of the manufacturer.
(17) Any economic operator that either places PPE on the market under its own name or trademark or modifies a productPPE in such a way that compliance with the requirements of this Regulation may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.
(18) Distributors and importers, being close to the market place, should only be involved in market surveillance tasks carried out by competent national authorities when any conflict of interest can be avoided, and should be prepared to participate actively, providing those authorities with all necessary information relating to the PPE concerned.
(18) Distributors and importers, being close to the market place, should be involved in market surveillance tasks carried out by competent national authorities, and shouldmust be prepared to participate actively, providing those authorities with all necessary information relating to the PPE concerned.
Jérôme LAVRILLEUX
(19) Ensuring traceability of PPE throughout the supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates the market surveillance authorities' task of tracing economic operators who made non-compliant product available on the market and to determine precisely, clearly and transparently the share of responsibility borne by each operator.
(19) Ensuring traceability of PPE throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates the market surveillance authorities' task of tracing economic operators who made non-compliant product available on the market.
(19) Ensuring traceability of PPE throughout the supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates the market surveillance authorities' task of tracing economic operators who made non-compliant productPPE available on the market.
(21) It is necessary to clearly specify the relationship and scope of this Regulation with the entitlement of Member States to lay down requirements for the use of PPE at workplace, in particular pursuant to Council Directive 89/656/EEC19 , in order to avoid any confusion and ambiguity and hence ensure the free movement of compliant PPE. Article 4 of that Directive obliges employers to provide PPE which complies with the relevant Union provisions on design and manufacture with respect to health and safety. Pursuant to that Article, manufacturers of PPE who provide that PPE to their employees must ensure that such PPE fulfils the requirements laid down in this Regulation. __________________ 19 Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace (OJ L 393, 30.12.1989, p. 18).
(24) In order to ensure that PPE is examined on the basis of the state of the art the limit of validity of the EU type- examination certificate should set to a maximum of fiseven years. A process for reviewing the certificate should be provided for. Such review should consist of a simple and expedient procedure. A minimum content of the certificate should be required in order to facilitate the work of the market surveillance authorities.
(27) The CE marking should be the only marking indicating that PPE is in conformity with Union harmonisation legislation. However, other markings should be allowed as long as they contribute to the improvement of consumer health and safety protection and are not covered by Union harmonisation legislation.
(28) In order to ensure compliance with the essential health and safety requirements, it is necessary to lay down appropriate conformity assessment procedures to be followed by the manufacturer. Directive 89/686/EEC classifies PPE into three categories that are subject to different conformity assessment procedures. In order to ensure a consistently high level of safety for all PPE, the list of products subject to one of the conformity assessment procedures relating to the production phase should be enlarged. The conformity assessment procedures for each category of PPE should be set, as far as possible, on the basis of the conformity assessment modules laid down in Decision No 768/2008/EC.
(28) In order to ensure compliance with the essential health and safety requirements laid down in this Regulation, it is necessary to lay down appropriate conformity assessment procedures to be followed by the manufacturer. Directive 89/686/EEC classifies PPE into three categories that are subject to different conformity assessment procedures. In order to ensure a consistently high level of safety for all PPE, the list of products subject to one of the conformity assessment procedures relating to the production phase should be enlarged. The conformity assessment procedures for each category of PPE should be set, as far as possible, on the basis of the conformity assessment modules laid down in Decision No 768/2008/EC.
(31) In order to take into account the progress of technical knowledge and new scientific evidence, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission to amend the list of PPE included in each category. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level and consult representatives of employee and employer's organisations from sectors that habitually make use of PPE in their operations. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.
(31) In order to take into account the progress of technical knowledge and new scientific evidence, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission to amend the list of PPE included in each category. It is of particular importance that the Commission carries out appropriate consultations and assesses the impact of its proposals during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.
(33) Member States should lay down rules on guidance, control and penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented bearing in mind that guidance is the best tool to avoid unintended mistakes by employers, manufacturers of PPE and end-users. Those penalties should be effective, proportionate and dissuasive.
(33) Member States should lay down rules on surveillance, control, sanctions and penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Those penalties and sanctions should be effective, proportionate and dissuasive.
(33) Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Those penalties should be imposed expediently, be effective, proportionate and dissuasive.
(33a) Member States should establish, preferably through cooperation between the surveillance authorities and the social partners, a single point of contact in which the end-users of the PPE can report flaws and errors concerning the PPE. The surveillance authorities are obliged to react to the report from the end-users in a fast and efficient manner.
Claude ROLIN
(33a) Directive 89/656/EEC lays down minimum requirements for personal protective equipment used by workers at work, and national provisions relating to safety at work make the use of PPE compulsory; Each Member State should therefore take suitable steps to encourage employers and workers to use appropriate PPE, including by providing employers, workers and trade unions with clear information about the compulsory nature of the use of PPE and by singling out as examples of best practice employers who apply these rules and observe general prevention principles as set out in Article 6(2) of Directive 89/391/EEC on the introduction of measures to encourage improvements in the safety and health of workers at work.
(35a) Special attention should be drawn to the field of undeclared work as, due to the impossibility of checking compliance with health and safety at work provisions, the conditions in the field of undeclared work allow workers to be exposed to high health risks and employers to escape liability. Domestic work, mainly performed by women, poses a particular challenge, as the work is in the informal sector, singularised and, by its nature, invisible.
(35b) Raising awareness about health and safety, including PPE, should be included in education curricula from an early age so as to bring down accident rates and increase health and safety; training on health and safety and PPE should be integrated especially into vocational training, fully recognised and attested by a diploma. Efforts should be made to substantially improve information and training for entrepreneurs. The results of research for new PPE, as the consequence of technology advances and new challenges, should be better disseminated.
(36) Directive 89/686/EEC has been amended several times. Since further substantial amendments are to be made and in order to ensure a uniform implementation throughout the Union, Directive 89/686/EEC should be repealed and replaced by a Regulation.
This Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) intended to be placed on the market in order to ensure the health and safety protection of users and rules on its free movement in the Union.
(c) intended for private use to protect against atmospheric conditions that are not of an extreme nature;:
i) atmospheric conditions that are not of an extreme nature (seasonal clothing, umbrellas etc.);
ii) damp and water (dish-washing gloves etc.);
iii) heat (gloves etc.) for which the economic operator does not explicitly claim a protective function against extreme heat;
Article 2 – paragraph 2 – point d
d) for use solely on seagoing vessels or aircraft that are subject to the relevant international treaties applicable in Member States;
Article 2 – paragraph 2 – point e
(e) for head, face or eye protection of users, subject to the relevant Regulation 22 of the United Nations Economic Commission for Europe (UNECE), of two- or three- wheeled motor vehiclen uniform provisions concerning the approval of protective helmets and of their visors for drivers and passengers of motor cycles and mopeds.
In that event, the health and safety of users shall be ensured as far as possible in the light of the objectives of this Regulation and in accordance with the European Framework Directive on Safety and Health at Work 89/391/EC.
a) equipment intenddesigned and manufactured to be worn or held by a person for protection against one or more risks for his or her health or safety that is placed on the market separately or combined with personal non-protective equipment;
(a) equipment intenddesigned and manufactured to be worn or held by a person for protection against one or more risks for his or her health or safety that is placed on the market separately or combined with personal non-protective equipment;
(c) connexion systems for equipment referred to in point (a) that are not held or worn by a person, but which are essential to the equipment's function, that are intended to connect that equipment to an external device or structure, that are removable and not intended to be permanently fixed to a structure;
2. 'individually adapted PPE' means PPE produced in series where each item is manufactured to fit an individual user in accordance with his or her special needs and characteristics;
3. 'made-to-measure PPE' means PPE produced as a single unit to accommodate the special needs of an individual user according to a basic model, following the instructions of the designmanufacturer of that basic model and respecting the range of permissible variations;
6a. 'end user' means the person who wears or uses the PPE;
Article 3 – paragraph 1 – point 18 a (new)
18a. 'Union harmonisation legislation' means any Union legislation harmonising the conditions for the marketing of products;
Member States shall take all appropriate and necessary measures to ensure and enforce that PPE is made available on the market only if, where properly maintained, its functioning clearly explained and used for its intended purpose, it complies with this Regulation.
PPE shall fulfil the applicable essential health and safety requirements set out in Annex II and in full compliance with Directive 89/391/EC.
This Regulation shall not affect Member States' entitlement, in particular when implementing Directive 89/656/EEC, to lay down requirements concerning the use of PPE provided that these requirements do not affect the design of PPE which is placed on the market in accordance with this Regulationare justified by an added value in terms of health and safety of the user.
Jutta STEINRUCK
Article -7 (new)
Article -7 Field tests In the context of a field test, a non- certified PPE may be handed over in limited quantities and for a maximum period of six months for testing or validation purposes. Prior to the start of the test, the manufacturer shall lay down the duration and purpose of the testing, and state the reasons why testing is required, and shall have these details confirmed by the parties concerned. Field tests of this kind shall be carried out only in non-dangerous situations and shall be performed to evaluate, inter alia, comfort, ergonomics or design. The parties concerned shall have access to the requisite test documents drawn up by accredited or authorised laboratories, which shall be attached to the technical documentation, with a view to ensuring that wearers are protected. Once the testing period is over, the PPE used shall be returned to the manufacturers. Field tests shall not be designed to test the protection performance of the PPE, but rather to assess, for example, comfort, ergonomics and design. All parties concerned (e.g. the employer and the wearer or end-user) shall be formally notified in advance of the scope and purpose of the field test.
2. At trade fairs, exhibitions, and demonstrations and similar events, Member States shall not prevent the showing of PPE which does not comply with this Regulation provided that a visible sign clearly indicates that the PPE does not comply with this Regulation and is not available on the market until it has been brought into conformity.
2. At trade fairs, exhibitions, and demonstrations, Member States shall not prevent the showing of PPE which does not comply with this Regulation provided that a visible signs can be found within the area assigned to the exhibiting party that clearly indicates that the PPE does not comply with this Regulation and is not available on the market until it has been brought into conformity.
During demonstrations and time-limited field tests, adequate measures shall be taken to ensure the protection of persons and to raise their awareness. A 'for field test only' marking shall be clearly and indelibly affixed to the PPE.
During demonstrations and field tests, adequate measures shall be taken to ensure the protection of persons and to raise their awareness. Field tests shall not only be designed to test the protection performance of the PPE, but to evaluate for instance comfort, ergonomics and design. All concerned parties (e.g. the employer as well as the wearer or end- user) shall be formally informed in advance concerning the scope and the purpose of this test. A 'for field test only' marking shall be clearly and indelibly affixed to the PPE.
The designmanufacturer of a basic model of made-to- measure PPE shall draw up the technical documentation referred to in Annex III and carry out the EU type- examination set out in Annex V or have them carried out.
6. Manufacturers shall indicate, on the PPE, their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the PPE. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by consumers and other end-users and market surveillance authorities.
7. Manufacturers shall ensure that the PPE is accompanied by the instructions set out in point 1.4 of Annex II in a language which can be easily understood by consumers and other end- users, as determined by the Member State concerned.
7. Manufacturers shall ensure that the PPE is accompanied by the instructions and other information set out in point 1.4 of Annex II in a language which can be easily understood by end- users, as determined by the Member State concerned.
7. Manufacturers shall ensure that the PPE is accompanied by the instructions set out in point 1.4 of Annex II in a language which can be easily understood by end- users, as determined by the Member State concerned as well as, where possible, by pictograms.
9. Manufacturers who consider or have reason to believe that PPE which they have placed on the market is not in conformity with this Regulation shall immediately take the necessary corrective measures to bring it into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, manufacturers shall immediately inform the market surveillance authorities of the Member States in which they made the PPE available on the market to that effect, giving details, in particular, of the non- conformity and of any corrective measures taken. The market surveillance authorities then have the obligation to inform the public of the risk as long as the corrective measure is not in place.
Laura AGEA
10. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary, in paper and electronic form, to demonstrate the conformity of the PPE, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have placed on the market.
Emilian PAVEL
10. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the PPE, in a language which can be easily understood bythe official language of that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have placed on the market.
10. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary, in paper or electronic form, to demonstrate the conformity of the PPE, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have placed on the market.
10. Manufacturers shall, further to a reasoned request from a competent national authority, provide it, in electronic or paper form, with all the information and documentation necessary to demonstrate the conformity of the PPE, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have placed on the market.
b) further to a reasoned request from a national market surveillancecompetent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the PPEan explosive;
(b) further to a reasoned request from a national market surveillance authority, provide that authority with all the information and documentation necessary, in paper and electronic form, to demonstrate the conformity of the PPE;
c) cooperate with the national market surveillancecompetent national authorities, at their request, on any action taken to eliminate the risks posed by PPE covered by the authorised representative's mandate.
2. Before placing PPE on the market, importers shall ensure that the appropriate conformity assessment procedure(s) referred to in Article 18 have been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the PPE bears the CE marking, is accompanied by the EU declaration of conformity or a simplified EU declaration of conformity, and that it is accompanied by the instructions referred to in Article 8(7)requisite documents and that the manufacturer has complied with the requirements set out in Article 8(5) and (6).
3. Importers shall indicate, on the PPE, their name, registered trade name or registered trade mark and the postal address at which they can be contacted, or where that is not possible, on its packaging or in a document accompanying the PPE. The contact details shall be in a language easily understood bythe official language of the end-users and market surveillance authorities.
4. Importers shall ensure that the PPE is accompanied by the instructions and other information referred to in point 1.4 of Annex II in a language which can be easily understood by consumers and other end- users, as determined by the Member State concerned.
4. Importers shall ensure that the PPE is accompanied by the instructions referred to in point 1.4 of Annex II in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned and when possible should be language neutral.
5a. When deemed appropriate with regard to the risks presented by PPE, importers shall, to protect the health and safety of consumers and other end-users, carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non- conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring.
6. Importers who consider or have reason to believe that PPE which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring the PPE into conformity, to withdraw it or to recall it, as appropriate. Such action should be taken no later than five working works days from the day on which importers become aware of that information. Furthermore, where the PPE presents a risk, importers shall immediately inform the market surveillance authorities of the Member States in which they made the PPE available on the market to that effect, giving details, in particular, of the non- conformity and of any corrective measures taken.
6. Importers who consider or have reason to believe that PPE which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring the PPE into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, importers shall immediately inform the market surveillance authorities of the Member States in which they made the PPE available on the market to that effect, giving details, in particular, of the non- conformity and of any corrective measures taken. The market surveillance authorities then have the obligation to inform the public of the risk as long as the corrective measure is not in place.
8. Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper orand electronic form, necessary to demonstrate the conformity of PPE in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have placed on the market.
2. Before making PPE available on the market, distributors shall verify that it bears the CE marking, is accompanied by the EU declaration of conformity or a simplified EU declaration of conformity, and that it is accompanied by required documents, by the instructions and other instrucformations set out in point 1.4 of Annex II in a language which can be easily understood by end- users in the Member State in which PPE is to be made available on the market and that the manufacturer and the importer have complied with the requirements set out in Article 8(5) and (6) and Article 10(3).
2. Before making PPE available on the market, distributors shall verify that it bears the CE marking, is accompanied by the EU declaration of conformity or a simplified EU declaration of conformity, and that it is accompanied by the instructions set out in point 1.4 of Annex II in a language which can be easily understood bythe official language of the end-users in the Member State in which PPE is to be made available on the market and that the manufacturer and the importer have complied with the requirements set out in Article 8(5) and (6) and Article 10(3).
2. Before making PPE available on the market, distributors shall verify that it bears the CE marking, is accompanied by the EU declaration of conformity or a simplified EU declaration of conformity, and that it is accompanied by the instructions and other information set out in point 1.4 of Annex II in a language which can be easily understood by end- users in the Member State in which PPE is to be made available on the market and that the manufacturer and the importer have complied with the requirements set out in Article 8(5) and (6) and Article 10(3).
Where a distributor considers or has reason to believe that PPE is not in conformity with the applicable essential health and safety requirements set out in Annex II, he shall not make the PPE available on the market until it has been brought into conformity. Furthermore, where the PPE presents a risk, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities. Thereafter, the manufacturer shall immediately recall the EPP from the market. The market surveillance authorities then have the obligation to inform the public of the risk as long as the corrective measure is not in place.
4. Distributors who consider or have reason to believe that PPE which they have made available on the market is not in conformity with the requirements of this Regulation shall make sure that the necessary corrective measures are taken to bring it into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, distributors shall immediately inform the market surveillance authorities of the Member States in which they have made the PPE available on the market to that effect, giving details, in particular, of the non- conformity and of any corrective measures taken. The market surveillance authorities then have the obligation to inform the public of the risk as long as the corrective measure is not in place.
An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and he shall be subject to the obligations of the manufacturer set out in Article 8 where he places PPE on the market under his name or trademark or modifies PPE already placed on the market in such a way that the conformity with the applicable essential health and safety requirements set out in Annex IIcompliance with this Regulation may be affected.
2. The CE marking shall be affixed visibly, legibly and indelibly to the PPE. Where that is not possible or not warranted on account of the nature of the PPE, it shall be affixed visibly, legibly and indelibly to the packaging and to the accompanying documents.
2. A conformity assessment body shall be established under the national law of each Member State and have legal personality.
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly or indirectly involved in the design, manufacture, making available, marketing, use or maintenance of PPE, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.
Article 23 – paragraph 7 – point c
(c) appropriate knowledge and understanding of the essential health and safety requirements set out in Annex II, of the corresponding harmonised standards and of the relevant provisions of Union harmonisation legislation and of relevant national legislation;
9. Conformity assessment bodies shall take out liability insurance unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the conformity assessmentDoes not affect the English version.
9. Conformity assessment bodies shall take out liability insurance unless liability is assumed by the Member State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment.
11. Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under this Regulation and shall apply as general guidance the administrativthe decisions and documents produced as a result of the work of that group.
1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractors or the subsidiaryies along the full compliance chain meets the requirements set out in Article 23 and shall inform the notifying authority accordingly.
Article 39 – title
PSurveillance, control, sanctions and penalties
Member States shall lay down the rules on guidance, control and penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. To avoid inaccurate use of the PPE and unintended flaws, Member States shall provide guidance on how to meet the requirements of this Regulation. Member States shall first and foremost provide the necessary guidance on how to meet the requirements of this Regulation. If, however, after receiving the necessary guidance the requirements are still not met, penalties shall be the next step. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by [3 months prior to the date of application of this Regulation] at the latest and shall notify it without delay of any subsequent amendment affecting them.
Member States shall lay down the rules on surveillance, control, sanctions and penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties or sanctions provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by [3 months prior to the date of application of this Regulation] at the latest and shall notify it without delay of any subsequent amendment affecting them.
Annex I – section 2 – point b
Annex I – section 3 – introductory part
PPE intended to protect users against very serious risks, such as death or irreversible damage to health. Category III includes exclusively PPE intended to protect users against the following risks:
Annex I – section 3 – point l a (new)
Annex II – heading -1 (new)
PRELIMINARY REMARKS 1. The essential health and safety requirements laid down in this Regulation are compulsory. 2. Obligations under essential health and safety requirements apply only where the corresponding risk exists for the PPE in question. 3. The essential requirements are to be interpreted and applied in such a way as to take into account the state of the art and current practice at the time of design and manufacture as well as of technical and economic considerations which are consistent with a high degree of health and safety protection. 4. The manufacturer is under an obligation to carry out a risk assessment in order to identify all the risks which apply to the PPE. The manufacturer shall then design and manufacture it taking into account of the assessment. 5. When designing and manufacturing the PPE, and when drafting the instructions, the manufacturer shall envisage not only the intended use of the PPE, but also the reasonably foreseeable uses. Where applicable, the health and safety of persons other than the user shall be ensured.
Annex II – part 1 – point 1.2 – point 1.2.1 – point 1.2.1.1
The materials, of which the PPE is made, including any of their possible decomposition products, must not adversely affect the health or safety of users or result in the PPE no longer complying with the essential health and safety requirements laid down in this Regulation.
Annex II – part 1 – point 1.4 – heading
Annex II – part 1 – point 1.4 – paragraph 1 – point e
e) where applicable, the date or period of obsolescence of the PPE or of certain of its components;
The identification markings or indicators directly or indirectly relating to health and safety affixed to these types of PPE must, if possible, take the form of harmonized pictograms or ideograms. They must be perfectly visible and legible and remain so throughout the foreseeable useful life of the PPE. In addition, these markings must be complete, precise and comprehensible so as to prevent any misinterpretation; in particular, when such markings include words or sentences, the latter must be written in the official language(s) ofa language easily understood by consumers and end-users, as determined by the Member State where the equipment is to be usedmade available on the market.
To this end, eye protective glassesequipment must be so designed and manufactured as to possess, for each harmful wave length, a spectral transmission factor such that the radiant- energy illumination density capable of reaching the user's eye through the filter is minimized and, under no circumstances, exceeds the maximum permissible exposure value. PPE designed to protect the skin against non-ionising radiation must be capable of absorbing or reflecting the majority of the energy radiated in the harmful wavelengths;
Annex IV – paragraph 1 – point 1
1. Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the PPE concerned satisfies the applicable essential health and safety requirements referred to in Article 5 and set out in Annex IIrequirements of this Regulation.
Annex IV – paragraph 1 – point 4 – point 4.1
4.1. The manufacturer shall affix the CE marking to each individual PPE that satisfies the applicable essential health and safety requirementsrequirements of this Regulation.
Annex V – paragraph 1 – point 9
9. The manufacturer shall keep a copy of the EU type-examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the PPE has been placedmade available on the market.
Annex VI – paragraph 1 – point 3 – point 3.1
3.1. The manufacturer shall affix the CE marking to each individual PPE that is in conformity with the type described in the EU type-examination certificate and satisfies the applicable essential health and safety requirementsrequirements of this Regulation.
Annex VII – paragraph 1 – point 1
1. Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 5.2 and 6, and ensures and declares on his sole responsibility that the PPE, which has been subject to the provisions of point 4, is in conformity with the type described in the EU type- examination certificate and satisfies the applicable essential health and safety requirements referred to in Article 5 and set out in Annex IIrequirements of this Regulation.
Annex VIII – paragraph 1 – point 6 – introductory part
6. The manufacturer shall, for a period ending 10 years after the PPE has been placedmade available on the market, keep at the disposal of the national authorities:
Filter history Activities Activities.body Activities.commission Activities.committees Activities.committees.date Activities.committees.rapporteur Activities.committees.shadows Activities.date Activities.docs Activities.docs.celexid Activities.docs.text Activities.type Commission Committees Committees.date Committees.rapporteur Committees.shadows Council Docs Docs.body Docs.docs.url Events Events.docs Events.docs.url Events.type Links Links.european commission.title Other Otherinst Procedure Procedure.dossier_of_the_committee Procedure.final Procedure.final.url Procedure.instrument Procedure.legal_basis Procedure.mandatory consultation of other institutions Procedure.modified legal basis Procedure.other legal basis Procedure.other_consulted_institutions Procedure.stage_reached Procedure.subject Procedure.summary
MAŠTÁLKA Jiří
https://www.europarl.europa.eu/doceo/document/IMCO-PR-546721_EN.html
https://www.europarl.europa.eu/doceo/document/IMCO-AM-549462_EN.html
https://www.europarl.europa.eu/doceo/document/EMPL-AD-544202_EN.html
The Committee on the Internal Market and Consumer Protection adopted the report by Vicky FORD (ECR, UK) on the proposal for a regulation of the European Parliament and of the Council on personal protective equipment. The committee recommended that Parliament's position adopted at first reading following the ordinary legislative procedure should amend the Commission proposal as follows: Purpose and scope : the Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) which is being made available on the market in order to ensure the protection of users and rules on its free movement in the Union. Amendments aiming to include in the scope of the Regulation equipment to protect against oxygen deficiency (e.g. diving equipment), chemicals, biological agents and radiation/radioactive contamination, laser radiation and radioactive contamination, and explosive fragments are now inserted into Annex I, Category III. Excluded from the scope of the legislation are PPE: designed to be used for self-defence, with the exception of PPE intended for sporting activities; intended for private use to protect against: (i) damp and water not of an extreme nature; (ii) heat, for which the economic operator does not explicitly describe and market the products as having a protective function; in the form of clothing intended for private use, with reflective or fluorescent garments which are exclusively included for reasons of design or decoration, and for which the economic operator does not describe and market the products as having a protective function; designed and placed on the market as artisanal products which are decorative in nature. Definitions: Members wanted to see more specific technical provisions, regarding: connection systems as items essential to the PPE's function; adding a definition of 'demonstration' and 'field test' and permitting field testing to take place. Field tests should not be designed to test the protection performance of the PPE but to evaluate other non-protective aspects such as comfort, ergonomics and design. Obligations of economic operators (manufacturers, importers, distributors): Manufacturers should: keep the technical documentation and the EU declaration of conformity for at least five years after the PPE has been placed on the market (rather than 10 years as proposed by the Commission); ensure that instructions , as well as any labelling, are clear, understandable and intelligible; ensure that performance as recorded during relevant technical tests to check the levels of classes of protection provided by the PPE is available electronically or upon request. Manufacturers should include with the EPP either the simplified EU declaration of conformity or include in the instructions or information leaflet the web site address where the EU declaration of conformity might be seen. Importers should: indicate, on the PPE their contact details in the official language or languages of the Member State(s) in which the PPE is to be marketed; ensure that PPE is accompanied by the instructions and safety information in a language which can be easily understood by consumers; with regard to the risks presented by PPE, carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring. Members stressed that importers and distributors should immediately inform the manufacturer and the competent national authorities if they have reason to believe that PPE that they have placed on the market is not in conformity with the Regulation. Examination certificate : the PPE should be examined on the basis of the latest scientific evidence. The maximum period of validity of the EU type-examination certificate should be five years and a process for reviewing the certificate should be provided. Following a positive review, a renewed certificate may continue to be valid for further periods, each of which should be for a maximum of five years. Presumption of conformity: unless otherwise provided for by Union harmonisation legislation, the withdrawal of a harmonised standard shall not invalidate existing certificates issued by notified bodies. Products produced in accordance with the existing certificate shall still benefit from continuing conformity with the essential requirements and may continue to be placed on the market until the end of the validity of the relevant certificates issued by notified bodies. CE marking : the CE marking and, where applicable, the identification number of the notified body may be accompanied by a pictogram or other marking indicating the risk against which the PPE is intended to protect. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking. Notification of conformity assessment bodies : accreditation should be the general rule for notified bodies. Members also stipulated that: Member States must notify manufacturers if a notified body has ceased activity; any appeal procedure must be transparent and accessible. Market surveillance : noting that the existing PPE legislation is in need of updating in line with the New Legislative Framework (NLF) on regulation of goods, Members introduced a new Chapter that will take into account: the requirements of the market surveillance regulation when the latter has been finalised; Union market surveillance and control of products entering the Union market; procedure applicable to PPE presenting a risk at national level, safeguard measures, etc. Requirements for employers : Members clarified the requirements for employers who provide PPE to their employees. Accordingly, employers shall provide PPE that complies with the relevant Union provisions on design and manufacture with respect to safety and health.
events/8/docs
url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20160119&type=CRE title: Debate in Parliament
events/10
The European Parliament adopted by 577 votes to 48, with 86 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council on personal protective equipment. Parliament's position, adopted at first reading following the ordinary legislative procedure, amended the Commission proposal as follows: Purpose and scope : the Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) which is to be made available on the market, in order to ensure protection of the health and safety of users . Amendments aiming to include in the scope of the Regulation equipment to protect against cleaning materials of weak action or prolonged contact with water. Other substances and mixtures which are hazardous to health include atmospheres with oxygen deficiency and harmful biological agents which are now inserted into Annex I, Category III which includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health. Excluded from the scope of the legislation are PPE: designed to be used for self-defence, with the exception of PPE intended for sporting activities; designed for private use to protect against atmospheric conditions that are not of an extreme nature and damp and water during dishwashing; for exclusive use on seagoing vessels or aircraft that are subject to the relevant international treaties applicable in Member States; for head, face or eye protection of users, that is covered by Regulation No 22 of the United Nations Economic Commission for Europe on uniform provisions concerning the approval of protective helmets and their visors for drivers and passengers of motor cycles and mopeds. Definitions : PPE should also mean: equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety; connexion systems for equipment that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use. Obligations of economic operators (manufacturers, importers, distributors) : Manufacturers and importers shall, when deemed appropriate with regard to the risks presented by PPE, carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring. Manufacturers shall: ensure that the PPE is accompanied by the instructions and information, as well as any labelling, shall be clear, understandable, intelligible and legible; either provide the EU declaration of conformity with the PPE or include in the instructions and information the internet address at which the EU declaration of conformity can be accessed; further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the PPE with this Regulation. CE marking : the CE marking shall be affixed before the PPE is placed on the market . The CE marking and, where applicable, the identification number of the notified body may be followed by a pictogram or other marking indicating the risk against which the PPE is intended to protect. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking. Accreditation system : in the recitals, it is stipulated that the system set out in this Regulation should be complemented by the accreditation system provided for in Regulation (EC) No 765/2008 . Transparent accreditation ensuring the necessary level of confidence in certificates of conformity , should be considered by the national public authorities throughout the Union as the preferred means of demonstrating the technical competence of conformity assessment bodies. However, national authorities may consider that they possess the appropriate means of carrying out that evaluation themselves. In such cases, in order to ensure the appropriate level of credibility of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with the necessary documentary evidence demonstrating the compliance of the conformity assessment bodies evaluated with the relevant regulatory requirements Appeal against decisions of notified bodies : notified bodies shall ensure that a transparent and accessible appeal procedure against their decisions is available. Market surveillance : in line with the New Legislative Framework (NLF) on regulation of goods and in order to ensure legal certainty, Parliament proposed to clarify that rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to PPE covered by this Regulation. Members also introduced provisions relating to the procedure at national level for dealing with PPE presenting a risk, Union safeguard procedure as well as PPE presenting a risk for the health and safety of persons.
procedure/Modified legal basis
procedure/Other legal basis
procedure/instrument/1
Amended by 2017/0353(COD)
Repealing Directive 89/686/EEC Amended by 2017/0353(COD)
name: FORD Vicky date: 2014-07-17T00:00:00 group: European Conservatives and Reformists abbr: ECR
name: ARIMONT Pascal group: European People's Party (Christian Democrats) abbr: PPE name: WESTPHAL Kerstin group: Progressive Alliance of Socialists and Democrats abbr: S&D name: ROCHEFORT Robert group: Alliance of Liberals and Democrats for Europe abbr: ALDE name: MAŠTÁLKA Jiří group: European United Left - Nordic Green Left abbr: GUE/NGL name: DURAND Pascal group: Greens/European Free Alliance abbr: Verts/ALE
name: FORD Vicky group: European Conservatives and Reformists abbr: ECR
name: AGEA Laura date: 2014-09-30T00:00:00 group: Europe of Freedom and Direct Democracy abbr: EFDD
name: AGEA Laura group: Europe of Freedom and Direct Democracy abbr: EFDD
events/10/docs/0/url
date: 2014-03-27T00:00:00 docs: url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2014&nu_doc=0186 title: COM(2014)0186 type: Legislative proposal published celexid: CELEX:52014PC0186:EN body: EC commission: DG: url: http://ec.europa.eu/enterprise/ title: Enterprise and Industry Commissioner: TAJANI Antonio type: Legislative proposal published
date: 2014-04-02T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP responsible: False committee_full: Employment and Social Affairs committee: EMPL body: EP responsible: False committee: EMPL date: 2014-09-30T00:00:00 committee_full: Employment and Social Affairs rapporteur: group: EFD name: AGEA Laura body: EP responsible: False committee_full: Environment, Public Health and Food Safety committee: ENVI body: EP responsible: True committee_full: Internal Market and Consumer Protection committee: IMCO body: EP responsible: True committee: IMCO date: 2014-07-17T00:00:00 committee_full: Internal Market and Consumer Protection rapporteur: group: ECR name: FORD Vicky body: EP responsible: False committee_full: Industry, Research and Energy committee: ITRE
body: CSL meeting_id: 3353 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=3353*&MEET_DATE=04/12/2014 type: Debate in Council title: 3353 council: Competitiveness (Internal Market, Industry, Research and Space) date: 2014-12-04T00:00:00 type: Council Meeting
date: 2015-04-23T00:00:00 body: unknown type: Committee decision to open interinstitutional negotiations with report adopted in committee
date: 2015-04-23T00:00:00 body: EP type: Vote in committee, 1st reading/single reading committees: body: EP responsible: False committee_full: Employment and Social Affairs committee: EMPL body: EP responsible: False committee: EMPL date: 2014-09-30T00:00:00 committee_full: Employment and Social Affairs rapporteur: group: EFD name: AGEA Laura body: EP responsible: False committee_full: Environment, Public Health and Food Safety committee: ENVI body: EP responsible: True committee_full: Internal Market and Consumer Protection committee: IMCO body: EP responsible: True committee: IMCO date: 2014-07-17T00:00:00 committee_full: Internal Market and Consumer Protection rapporteur: group: ECR name: FORD Vicky body: EP responsible: False committee_full: Industry, Research and Energy committee: ITRE
body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A8-2015-0148&language=EN type: Committee report tabled for plenary, 1st reading/single reading title: A8-0148/2015 type: Committee report tabled for plenary, 1st reading/single reading committees: body: EP responsible: False committee_full: Employment and Social Affairs committee: EMPL body: EP responsible: False committee: EMPL date: 2014-09-30T00:00:00 committee_full: Employment and Social Affairs rapporteur: group: EFD name: AGEA Laura body: EP responsible: False committee_full: Environment, Public Health and Food Safety committee: ENVI body: EP responsible: True committee_full: Internal Market and Consumer Protection committee: IMCO body: EP responsible: True committee: IMCO date: 2014-07-17T00:00:00 committee_full: Internal Market and Consumer Protection rapporteur: group: ECR name: FORD Vicky body: EP responsible: False committee_full: Industry, Research and Energy committee: ITRE date: 2015-04-30T00:00:00
date: 2016-01-20T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P8-TA-2016-0012 type: Decision by Parliament, 1st reading/single reading title: T8-0012/2016 body: EP type: Decision by Parliament, 1st reading/single reading
date: 2016-02-12T00:00:00 body: CSL type: Council Meeting council: Economic and Financial Affairs ECOFIN meeting_id: 3445
date: 2016-03-31T00:00:00 docs: url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32016R0425 title: Regulation 2016/425 url: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2016:081:TOC title: OJ L 081 31.03.2016, p. 0051 type: Final act published in Official Journal
body: EC dg: Internal Market, Industry, Entrepreneurship and SMEs commissioner: TAJANI Antonio
Former Responsible Committee
group: EFD name: AGEA Laura
group: ECR name: FORD Vicky
Former Committee Opinion
body: CSL type: Council Meeting council: Economic and Financial Affairs ECOFIN meeting_id: 3445 url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=3445*&MEET_DATE=12/02/2016 date: 2016-02-12T00:00:00
body: CSL type: Council Meeting council: Competitiveness (Internal Market, Industry, Research and Space) meeting_id: 3353 url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=3353*&MEET_DATE=04/12/2014 date: 2014-12-04T00:00:00
date: 2015-04-07T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE544.202&secondRef=03 title: PE544.202 committee: EMPL type: Committee opinion body: EP
date: 2015-10-12T00:00:00 docs: title: GEDA/A/(2015)010800 type: Coreper letter confirming interinstitutional agreement body: CSL
date: 2014-03-27T00:00:00 type: Legislative proposal published body: EC docs: url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2014&nu_doc=0186 title: EUR-Lex title: COM(2014)0186 summary: PURPOSE: to lay down requirements for the design and manufacture of personal protective equipment (PPE) in order to ensure the health and safety protection of users and rules on its free movement in the Union. PROPOSED ACT: Regulation of the European Parliament and the Council. ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: Directive 89/686/EEC on personal protective equipment was adopted on 21 December 1989 and became fully applicable as from 1 July 1995. It sets out basic requirements that PPE must comply with in order to be made available on the EU market. The PPE Directive applies to PPE that is defined as "any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards". While the directive has successfully achieved its objectives in creating a single market and ensuring a high level of protection for users of PPE, certain problems have been encountered in its implementation. These concern products on the market that do not ensure an adequate level of protection, diverging approaches of the notified bodies, the effectiveness of the market surveillance as well as risks related to protective equipment which is currently not covered by the PPE Directive. The proposal modifies and clarifies a number of the provisions of the existing Directive and aligns it with the provisions of Decision No 768/2008/EC establishing a common framework for the marketing of products (NLF Decision). The Commission has already proposed the alignment of nine Directives to the NLF Decision within an NLF implementation package adopted on 21 November 2011. IMPACT ASSESSMENT: the preferred option consists of amending the PPE Directive as it: (i) lead to an improved level of protection of the health and safety of the users; (ii) ensures a more effective work of the market surveillance authorities and consequently reduces the non-compliant products; (iii) does not entail significant costs for economic operators and notified bodies. CONTENT: this proposal intends to replace Directive 89/686/EEC on personal protective equipment by a Regulation. Its general objectives are to ensure a high level of protection of human health and safety whilst guaranteeing fair competition for economic operators on the Union market and simplifying the regulatory environment in this area. The proposal also clarifies a number of provisions of the existing Directive and aligns it with those of the Decision No 768/2008/EC establishing a common framework for the marketing of products (decision on the new legislative framework). Scope : the Commission proposes to enlarge the scope of the current PPE Directive by deleting the exclusions of PPE designed and manufactured for private use against heat, damp and water . The proposal keeps the other existing exclusions and clarifies that it does not apply to PPE for head, face or eye protection, subject to the relevant UNECE Regulation, of users of two- or three-wheeled motor vehicles. Two PPE specific definitions have been added in order to clarify the applicable conformity assessment procedures: " Individually adapted PPE " and " Made-to-measure PPE ". Making available on the market, free movement, obligations of economic operators, CE marking : the proposal: contains the typical provisions for product-related Union harmonisation legislation and sets out the obligations of the relevant economic operators (manufacturers, authorised representatives, importers and distributors), in accordance with the NLF Decision; obliges the manufacturer of PPE to draw up a technical documentation and to ensure that the PPE is accompanied by a copy of the EU declaration of conformity or a simplified EU declaration of conformity. Notified bodies : the proposal sets out requirements for national authorities responsible for conformity assessment bodies (notified bodies). It leaves the ultimate responsibility for designating and monitoring notified bodies with the individual Member State. Categories and Conformity assessment : the proposal simplifies the definition of the categories of PPE. The category only depends on the risk against which the PPE is intended to protect. Provisions are set out for made-to-measure PPE. PPE intended to protect the user against drowning, cuts by hand-held chain-saws, high-pressure cutting, bullet wounds or knife stabs, and harmful noise are subject to the most stringent conformity assessment procedure . Minor amendments have been made which change marginally three essential health and safety requirements (EHSR) in order to remove requirements shown to be impracticable or that create confusion. Application : the proposed Regulation will become applicable two years after its entry into force to allow manufacturers, notified bodies and Member States time to adapt to the new requirements. However, the designation of notified bodies pursuant to the new requirements and process needs to start shortly after the entry into force of this Regulation. Transitional provisions are foreseen for products manufactured and the certificates issued by notified bodies under Directive 89/686/EEC so as to allow stocks to be absorbed and ensure a smooth transition to the new requirements. DELEGATED ACTS: this proposal contains provisions empowering the Commission to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union.
date: 2015-04-23T00:00:00 type: Committee decision to open interinstitutional negotiations with report adopted in committee body: EP
date: 2015-04-30T00:00:00 type: Committee report tabled for plenary, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A8-2015-0148&language=EN title: A8-0148/2015 summary: The Committee on the Internal Market and Consumer Protection adopted the report by Vicky FORD (ECR, UK) on the proposal for a regulation of the European Parliament and of the Council on personal protective equipment. The committee recommended that Parliament's position adopted at first reading following the ordinary legislative procedure should amend the Commission proposal as follows: Purpose and scope : the Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) which is being made available on the market in order to ensure the protection of users and rules on its free movement in the Union. Amendments aiming to include in the scope of the Regulation equipment to protect against oxygen deficiency (e.g. diving equipment), chemicals, biological agents and radiation/radioactive contamination, laser radiation and radioactive contamination, and explosive fragments are now inserted into Annex I, Category III. Excluded from the scope of the legislation are PPE: designed to be used for self-defence, with the exception of PPE intended for sporting activities; intended for private use to protect against: (i) damp and water not of an extreme nature; (ii) heat, for which the economic operator does not explicitly describe and market the products as having a protective function; in the form of clothing intended for private use, with reflective or fluorescent garments which are exclusively included for reasons of design or decoration, and for which the economic operator does not describe and market the products as having a protective function; designed and placed on the market as artisanal products which are decorative in nature. Definitions: Members wanted to see more specific technical provisions, regarding: connection systems as items essential to the PPE's function; adding a definition of 'demonstration' and 'field test' and permitting field testing to take place. Field tests should not be designed to test the protection performance of the PPE but to evaluate other non-protective aspects such as comfort, ergonomics and design. Obligations of economic operators (manufacturers, importers, distributors): Manufacturers should: keep the technical documentation and the EU declaration of conformity for at least five years after the PPE has been placed on the market (rather than 10 years as proposed by the Commission); ensure that instructions , as well as any labelling, are clear, understandable and intelligible; ensure that performance as recorded during relevant technical tests to check the levels of classes of protection provided by the PPE is available electronically or upon request. Manufacturers should include with the EPP either the simplified EU declaration of conformity or include in the instructions or information leaflet the web site address where the EU declaration of conformity might be seen. Importers should: indicate, on the PPE their contact details in the official language or languages of the Member State(s) in which the PPE is to be marketed; ensure that PPE is accompanied by the instructions and safety information in a language which can be easily understood by consumers; with regard to the risks presented by PPE, carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring. Members stressed that importers and distributors should immediately inform the manufacturer and the competent national authorities if they have reason to believe that PPE that they have placed on the market is not in conformity with the Regulation. Examination certificate : the PPE should be examined on the basis of the latest scientific evidence. The maximum period of validity of the EU type-examination certificate should be five years and a process for reviewing the certificate should be provided. Following a positive review, a renewed certificate may continue to be valid for further periods, each of which should be for a maximum of five years. Presumption of conformity: unless otherwise provided for by Union harmonisation legislation, the withdrawal of a harmonised standard shall not invalidate existing certificates issued by notified bodies. Products produced in accordance with the existing certificate shall still benefit from continuing conformity with the essential requirements and may continue to be placed on the market until the end of the validity of the relevant certificates issued by notified bodies. CE marking : the CE marking and, where applicable, the identification number of the notified body may be accompanied by a pictogram or other marking indicating the risk against which the PPE is intended to protect. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking. Notification of conformity assessment bodies : accreditation should be the general rule for notified bodies. Members also stipulated that: Member States must notify manufacturers if a notified body has ceased activity; any appeal procedure must be transparent and accessible. Market surveillance : noting that the existing PPE legislation is in need of updating in line with the New Legislative Framework (NLF) on regulation of goods, Members introduced a new Chapter that will take into account: the requirements of the market surveillance regulation when the latter has been finalised; Union market surveillance and control of products entering the Union market; procedure applicable to PPE presenting a risk at national level, safeguard measures, etc. Requirements for employers : Members clarified the requirements for employers who provide PPE to their employees. Accordingly, employers shall provide PPE that complies with the relevant Union provisions on design and manufacture with respect to safety and health.
date: 2015-11-10T00:00:00 type: Approval in committee of the text agreed at 1st reading interinstitutional negotiations body: EP docs: url: http://www.europarl.europa.eu/RegData/commissions/imco/inag/2017/09-22/IMCO_AG(2017)610792_EN.pdf title: PE610.792
date: 2016-01-20T00:00:00 type: Decision by Parliament, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P8-TA-2016-0012 title: T8-0012/2016 summary: The European Parliament adopted by 577 votes to 48, with 86 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council on personal protective equipment. Parliament's position, adopted at first reading following the ordinary legislative procedure, amended the Commission proposal as follows: Purpose and scope : the Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) which is to be made available on the market, in order to ensure protection of the health and safety of users . Amendments aiming to include in the scope of the Regulation equipment to protect against cleaning materials of weak action or prolonged contact with water. Other substances and mixtures which are hazardous to health include atmospheres with oxygen deficiency and harmful biological agents which are now inserted into Annex I, Category III which includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health. Excluded from the scope of the legislation are PPE: designed to be used for self-defence, with the exception of PPE intended for sporting activities; designed for private use to protect against atmospheric conditions that are not of an extreme nature and damp and water during dishwashing; for exclusive use on seagoing vessels or aircraft that are subject to the relevant international treaties applicable in Member States; for head, face or eye protection of users, that is covered by Regulation No 22 of the United Nations Economic Commission for Europe on uniform provisions concerning the approval of protective helmets and their visors for drivers and passengers of motor cycles and mopeds. Definitions : PPE should also mean: equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety; connexion systems for equipment that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use. Obligations of economic operators (manufacturers, importers, distributors) : Manufacturers and importers shall, when deemed appropriate with regard to the risks presented by PPE, carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring. Manufacturers shall: ensure that the PPE is accompanied by the instructions and information, as well as any labelling, shall be clear, understandable, intelligible and legible; either provide the EU declaration of conformity with the PPE or include in the instructions and information the internet address at which the EU declaration of conformity can be accessed; further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the PPE with this Regulation. CE marking : the CE marking shall be affixed before the PPE is placed on the market . The CE marking and, where applicable, the identification number of the notified body may be followed by a pictogram or other marking indicating the risk against which the PPE is intended to protect. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking. Accreditation system : in the recitals, it is stipulated that the system set out in this Regulation should be complemented by the accreditation system provided for in Regulation (EC) No 765/2008 . Transparent accreditation ensuring the necessary level of confidence in certificates of conformity , should be considered by the national public authorities throughout the Union as the preferred means of demonstrating the technical competence of conformity assessment bodies. However, national authorities may consider that they possess the appropriate means of carrying out that evaluation themselves. In such cases, in order to ensure the appropriate level of credibility of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with the necessary documentary evidence demonstrating the compliance of the conformity assessment bodies evaluated with the relevant regulatory requirements Appeal against decisions of notified bodies : notified bodies shall ensure that a transparent and accessible appeal procedure against their decisions is available. Market surveillance : in line with the New Legislative Framework (NLF) on regulation of goods and in order to ensure legal certainty, Parliament proposed to clarify that rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to PPE covered by this Regulation. Members also introduced provisions relating to the procedure at national level for dealing with PPE presenting a risk, Union safeguard procedure as well as PPE presenting a risk for the health and safety of persons.
date: 2016-03-31T00:00:00 type: Final act published in Official Journal summary: PURPOSE: to update internal market rules for personal protective equipment, in order to enhance consumer safety and ensure fair competition between companies. LEGISLATIVE ACT: Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC. CONTENT: the new Regulation updates the existing rules in directive 89/686/EEC. It lays down requirements for the design and manufacture of personal protective equipment (PPE), which is to be made available on the market, in order to ensure protection of the health and safety of users and establish rules on the free movement of PPE in the Union. Scope: personal protective equipment offers protection against all kinds of hazards (e.g. heat, flames, chemicals, flying particles, mechanical shocks, etc.) in a range of different environments, whether it be the home, at work or on the sports field. Examples include: head/ear/eye protection, breathing protection, body protection, and hand/leg/foot protection. Products intended for private use to protect against atmospheric conditions that are not of an extreme nature or to protect against damp and water, including dishwashing gloves, fall outside of the scope of the Regulation. This Regulation covers PPE which is new to the Union market when it is placed on the market; that is to say, it is either new PPE made by a manufacturer established in the Union or PPE, whether new or second-hand, imported from a third country. It applies to all forms of supply, including distance selling. Obligations of economic operators (manufacturers, importers, distributors): all economic operators intervening in the supply and distribution chain must take appropriate measures to ensure that they make available on the market only PPE which is in conformity with the Regulation. In particular, manufacturers must ensure that PPE has been designed and manufactured in accordance with the applicable essential health and safety requirements set out in Annex II. They must: · implement the conformity assessment procedures established by the Regulation. These procedures are linked to the degree of risk involved; · keep the technical documentation and the EU declaration of conformity for 10 years after the PPE has been placed on the market; · carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring; · ensure that the PPE which they place on the market bears a type, batch or serial number or other element allowing its identification; · indicate, on the PPE, their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the PPE; · ensure that instructions and safety information , as well as any labelling, is clear, understandable, intelligible and legible; · further to a reasoned request from a competent national authority , provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the PPE with the Regulation, in a language which can be easily understood by that authority; · immediately take the corrective measures necessary to bring PPE into conformity, to withdraw it or to recall it, as appropriate. For their part, importers must make sure that they do not place on the market PPE which does not comply with requirements or which present a risk. They must also make sure that the conformity assessment procedures have been carried out and that the CE marking and technical documentation drawn up by manufacturers are available for inspection by the competent national authorities. CE marking : the CE marking shall be affixed before the PPE is placed on the market and affixed visibly, legibly and indelibly to the PPE or affixed to the packaging and to the accompanying documents. The CE marking and, where applicable, the identification number of the notified body may be followed by a pictogram or other marking indicating the risk against which the PPE is intended to protect. Member States shall take appropriate action in the event of improper use of that marking. Notifying authorities : the Regulation sets requirements for notifying authorities responsible for conformity assessment bodies. These bodies must apply the conformity assessment procedures without creating unnecessary burdens for economic operators . Interested parties have the right to appeal against the result of a conformity assessment carried out by a notified body. Market surveillance : in the context of aligning the legislation on PPE with the new legislative framework for the marketing of products, and in order to ensure legal certainty, the rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to PPE covered by this Regulation. The new Regulation also contains provisions regarding procedures at national level for dealing with PPE presenting a risk, Union safeguard procedures, and compliant PPE which presents a risk to health and safety. Transitional provisions: Member States shall not impede the making available on the market of products covered by Directive 89/686/EEC which are in conformity with that Directive and which were placed on the market before 21 April 2019. ENTRY INTO FORCE: 20.4.2016. APPLICATION: from 21.4.2018, with the exception of certain provisions which apply from 21.10.2016 or from 21.3.2018. DELEGATED ACTS: the Commission may adopt delegated acts in respect of amending the categories of risks against which the PPE is intended to protect users. The power to adopt delegated acts shall be conferred on the Commission for a period of 5 years (which may be tacitly extended) from 21 April 2018. The European Parliament or the Council may raise objections to a delegated act within two months from the date of notification (which may be extended by two months). If the European Parliament or the Commission raise objections, the delegated act will not enter into force. docs: title: Regulation 2016/425 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32016R0425 title: OJ L 081 31.03.2016, p. 0051 url: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2016:081:TOC
body: EC dg: url: http://ec.europa.eu/enterprise/ title: Enterprise and Industry commissioner: TAJANI Antonio
Economic and Social Committee
procedure/instrument
3.40.17 Manufactured goods
Standardisation, EC/EU standards and trade mark, certification, compliance
Health and safety at work, occupational medicine
procedure/summary
Repealing Directive 89/686/EEC
activities/12
url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32016R0425 title: Regulation 2016/425 url: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2016:081:TOC title: OJ L 081 31.03.2016, p. 0051
Final act signed
activities/1/committees/3
group: EPP name: ARIMONT Pascal group: S&D name: WESTPHAL Kerstin group: ALDE name: ROCHEFORT Robert group: GUE/NGL name: MAŠTÁLKA Jiří group: Verts/ALE name: DURAND Pascal
Economic and Financial Affairs ECOFIN
Political agreement in Council on its 1st reading position
Purpose and scope: the Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) which is to be made available on the market, in order to ensure protection of the health and safety of users.
designed to be used for self-defence, with the exception of PPE intended for sporting activities;
designed for private use to protect against atmospheric conditions that are not of an extreme nature and damp and water during dishwashing;
for exclusive use on seagoing vessels or aircraft that are subject to the relevant international treaties applicable in Member States;
for head, face or eye protection of users, that is covered by Regulation No 22 of the United Nations Economic Commission for Europe on uniform provisions concerning the approval of protective helmets and their visors for drivers and passengers of motor cycles and mopeds.
Definitions: PPE should also mean:
equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety;
connexion systems for equipment that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use.
ensure that the PPE is accompanied by the instructions and information, as well as any labelling, shall be clear, understandable, intelligible and legible;
either provide the EU declaration of conformity with the PPE or include in the instructions and information the internet address at which the EU declaration of conformity can be accessed;
further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the PPE with this Regulation.
CE marking: the CE marking shall be affixed before the PPE is placed on the market. The CE marking and, where applicable, the identification number of the notified body may be followed by a pictogram or other marking indicating the risk against which the PPE is intended to protect. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.
Accreditation system: in the recitals, it is stipulated that the system set out in this Regulation should be complemented by the accreditation system provided for in Regulation (EC) No 765/2008.
Transparent accreditation ensuring the necessary level of confidence in certificates of conformity, should be considered by the national public authorities throughout the Union as the preferred means of demonstrating the technical competence of conformity assessment bodies.
Appeal against decisions of notified bodies: notified bodies shall ensure that a transparent and accessible appeal procedure against their decisions is available.
Market surveillance: in line with the New Legislative Framework (NLF) on regulation of goods and in order to ensure legal certainty, Parliament proposed to clarify that rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to PPE covered by this Regulation. Members also introduced provisions relating to the procedure at national level for dealing with PPE presenting a risk, Union safeguard procedure as well as PPE presenting a risk for the health and safety of persons.
url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20160119&type=CRE type: Debate in Parliament title: Debate in Parliament
Debate scheduled
url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P8-TA-2016-0012 type: Decision by Parliament, 1st reading/single reading title: T8-0012/2016
2.10.03 Standardisation, EC standards and trademark, certification, compliance
Committee decision to open interinstitutional negotiations with report adopted in committee
Purpose and scope: the Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) which is being made available on the market in order to ensure the protection of users and rules on its free movement in the Union.
intended for private use to protect against: (i) damp and water not of an extreme nature; (ii) heat, for which the economic operator does not explicitly describe and market the products as having a protective function;
in the form of clothing intended for private use, with reflective or fluorescent garments which are exclusively included for reasons of design or decoration, and for which the economic operator does not describe and market the products as having a protective function;
designed and placed on the market as artisanal products which are decorative in nature.
connection systems as items essential to the PPE's function;
adding a definition of 'demonstration' and 'field test' and permitting field testing to take place. Field tests should not be designed to test the protection performance of the PPE but to evaluate other non-protective aspects such as comfort, ergonomics and design.
keep the technical documentation and the EU declaration of conformity for at least five years after the PPE has been placed on the market (rather than 10 years as proposed by the Commission);
ensure that instructions, as well as any labelling, are clear, understandable and intelligible;
ensure that performance as recorded during relevant technical tests to check the levels of classes of protection provided by the PPE is available electronically or upon request.
indicate, on the PPE their contact details in the official language or languages of the Member State(s) in which the PPE is to be marketed;
ensure that PPE is accompanied by the instructions and safety information in a language which can be easily understood by consumers;
with regard to the risks presented by PPE, carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring.
Examination certificate: the PPE should be examined on the basis of the latest scientific evidence. The maximum period of validity of the EU type-examination certificate should be five years and a process for reviewing the certificate should be provided. Following a positive review, a renewed certificate may continue to be valid for further periods, each of which should be for a maximum of five years.
CE marking: the CE marking and, where applicable, the identification number of the notified body may be accompanied by a pictogram or other marking indicating the risk against which the PPE is intended to protect. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.
Notification of conformity assessment bodies: accreditation should be the general rule for notified bodies. Members also stipulated that:
Member States must notify manufacturers if a notified body has ceased activity;
any appeal procedure must be transparent and accessible.
Market surveillance: noting that the existing PPE legislation is in need of updating in line with the New Legislative Framework (NLF) on regulation of goods, Members introduced a new Chapter that will take into account: the requirements of the market surveillance regulation when the latter has been finalised; Union market surveillance and control of products entering the Union market; procedure applicable to PPE presenting a risk at national level, safeguard measures, etc.
Requirements for employers: Members clarified the requirements for employers who provide PPE to their employees. Accordingly, employers shall provide PPE that complies with the relevant Union provisions on design and manufacture with respect to safety and health.
url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A8-2015-0148&language=EN type: Committee report tabled for plenary, 1st reading/single reading title: A8-0148/2015
body: EP responsible: False committee: EMPL date: 2014-09-30T00:00:00 committee_full: Employment and Social Affairs rapporteur: group: EFD name: AGEA Laura body: EP responsible: False committee_full: Employment and Social Affairs committee: EMPL body: EP responsible: False committee_full: Environment, Public Health and Food Safety committee: ENVI body: EP shadows: group: EPP name: ARIMONT Pascal group: S&D name: WESTPHAL Kerstin group: ALDE name: ROCHEFORT Robert group: GUE/NGL name: MAŠTÁLKA Jiří group: Verts/ALE name: DURAND Pascal responsible: True committee: IMCO date: 2014-07-17T00:00:00 committee_full: Internal Market and Consumer Protection rapporteur: group: ECR name: FORD Vicky body: EP responsible: True committee_full: Internal Market and Consumer Protection committee: IMCO body: EP responsible: False committee_full: Industry, Research and Energy committee: ITRE
Competitiveness (Internal Market, Industry, Research and Space)
DURAND Pascal
body: EP responsible: False committee: EMPL date: 2014-09-30T00:00:00 committee_full: Employment and Social Affairs rapporteur: group: EFD name: AGEA Laura body: EP responsible: False committee_full: Employment and Social Affairs committee: EMPL body: EP responsible: False committee_full: Environment, Public Health and Food Safety committee: ENVI body: EP shadows: group: EPP name: ARIMONT Pascal group: S&D name: WESTPHAL Kerstin group: ALDE name: ROCHEFORT Robert group: GUE/NGL name: MAŠTÁLKA Jiří responsible: True committee: IMCO date: 2014-07-17T00:00:00 committee_full: Internal Market and Consumer Protection rapporteur: group: ECR name: FORD Vicky body: EP responsible: True committee_full: Internal Market and Consumer Protection committee: IMCO body: EP responsible: False committee_full: Industry, Research and Energy committee: ITRE
ARIMONT Pascal
WESTPHAL Kerstin
group: ALDE name: ROCHEFORT Robert
2.10.03 Standardisation, EC standards and trade mark, certification, compliance
Scope: the Commission proposes to enlarge the scope of the current PPE Directive by deleting the exclusions of PPE designed and manufactured for private use against heat, damp and water. The proposal keeps the other existing exclusions and clarifies that it does not apply to PPE for head, face or eye protection, subject to the relevant UNECE Regulation, of users of two- or three-wheeled motor vehicles.
Two PPE specific definitions have been added in order to clarify the applicable conformity assessment procedures: "Individually adapted PPE" and "Made-to-measure PPE".
Making available on the market, free movement, obligations of economic operators, CE marking: the proposal:
contains the typical provisions for product-related Union harmonisation legislation and sets out the obligations of the relevant economic operators (manufacturers, authorised representatives, importers and distributors), in accordance with the NLF Decision;
obliges the manufacturer of PPE to draw up a technical documentation and to ensure that the PPE is accompanied by a copy of the EU declaration of conformity or a simplified EU declaration of conformity.
Notified bodies: the proposal sets out requirements for national authorities responsible for conformity assessment bodies (notified bodies). It leaves the ultimate responsibility for designating and monitoring notified bodies with the individual Member State.
Categories and Conformity assessment: the proposal simplifies the definition of the categories of PPE. The category only depends on the risk against which the PPE is intended to protect. Provisions are set out for made-to-measure PPE. PPE intended to protect the user against drowning, cuts by hand-held chain-saws, high-pressure cutting, bullet wounds or knife stabs, and harmful noise are subject to the most stringent conformity assessment procedure.
Application: the proposed Regulation will become applicable two years after its entry into force to allow manufacturers, notified bodies and Member States time to adapt to the new requirements. However, the designation of notified bodies pursuant to the new requirements and process needs to start shortly after the entry into force of this Regulation.
url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2014&nu_doc=0186 celexid: CELEX:52014PC0186:EN type: Legislative proposal published title: COM(2014)0186
DG: url: http://ec.europa.eu/enterprise/ title: Enterprise and Industry Commissioner: TAJANI Antonio
body: EP responsible: False committee_full: Employment and Social Affairs committee: EMPL
body: EP responsible: True committee_full: Internal Market and Consumer Protection committee: IMCO
url: http://ec.europa.eu/enterprise/ title: Enterprise and Industry
TAJANI Antonio
procedure/legal_basis
Treaty on the Functioning of the EU TFEU 114
body: EP responsible: False committee_full: Employment and Social Affairs committee: EMPL body: EP responsible: False committee_full: Environment, Public Health and Food Safety committee: ENVI body: EP responsible: True committee_full: Internal Market and Consumer Protection committee: IMCO body: EP responsible: False committee_full: Industry, Research and Energy committee: ITRE
date: 2014-03-27T00:00:00 docs: url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2014&nu_doc=0186 celexid: CELEX:52014PC0186:EN type: Legislative proposal published title: COM(2014)0186 body: EC type: Legislative proposal published commission: DG: url: http://ec.europa.eu/enterprise/ title: Enterprise and Industry Commissioner: TAJANI Antonio
date: 2014-04-02T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP responsible: False committee_full: Employment and Social Affairs committee: EMPL body: EP responsible: False committee_full: Environment, Public Health and Food Safety committee: ENVI body: EP responsible: True committee_full: Internal Market and Consumer Protection committee: IMCO body: EP responsible: False committee_full: Industry, Research and Energy committee: ITRE
2.10.03 Standardisation, EC standards and trade mark, certification, compliance 3.40.17 Manufactured goods 4.15.15 Health and safety at work, occupational medicine 4.20 Public health 4.60.08 Safety of products and services, product liability

redpajama_set_name: RedPajamaCommonCrawl