What is EU law on personal protective equipment?
On April 21, 2018, Regulation (EU) 2016/425 of the European Parliament and of the Council of March 9, 2016 on personal protective equipment and repealing Council Directive 89/686 / EEC came into force.
The legal basis for the certification of protective clothing in Poland is the Regulation of the Minister of Economy of December 21, 2005 on the essential requirements for personal protective equipment (Journal of Laws 2005 No. 259 item 2173) implementing the provisions of the Council Directive of the European Communities No. Directive 89/686 / EEC was repealed with effect from April 21, 2018. From that moment, Regulation (EU) 2016/425 of the European Parliament and of the Council of March 9, 2016 on personal protective equipment and the repeal of the Council Directive 89 / 686 / EEC.
The regulation is directly applicable in all Member States, without having to be transposed into national law. Thanks to the adaptation to the New Legal Framework and taking into account the experience gained during the application of the PPE Directive, a modern set of provisions on personal protective equipment was created.
Basic changes introduced by the new regulation:
- Validity period of EU-type examination certificates (max. 5 years)
- The minimum content of the EC-type examination certificates
- Definitions of economic entities and their obligations
- Introduction of a reduction of difficulties related to administrative proceedings when extending EC-type examination certificates, i.e. simplification of procedures in the event when:
– the manufacturer has not changed the approved product type,
- the harmonized standard or other technical specifications have not changed (they still ensure the fulfillment of the essential safety and health requirements according to the current knowledge)
- Reference to a batch or series of products – manufacturers ensure that the PPE placed on the market bears the type name, batch or serial number or other information enabling their identification (it is allowed to include this information on the packaging or accompanying document of the PPE)
- Extension of the list of products subject to one of the conformity assessment procedures – PPE designed and manufactured for private use and protection against heat
- Declaration of Conformity more detailed
The new regulation 2016/425 does not change much from the point of view of the user, employer, person wearing PPE, as all the essential health and safety requirements have been transferred from Directive 89/686 EEC, adding some modifications. However, it introduces new obligations for producers:
- When placing PPE on the market, manufacturers ensure that they are designed and manufactured in accordance with the applicable essential health and safety requirements.
- Manufacturers prepare technical documentation
- Manufacturers draw up a declaration of conformity and affix the CE marking
- Manufacturers must keep the technical documentation and the EU declaration of conformity for 10 years after the PPE has been placed on the market
- Manufacturers ensure that procedures are in place to maintain serial production conformity
- Manufacturers must ensure that the PPE they place on the market bears a type name, batch or serial number or other information allowing their identification or – where the size or nature of the PPE does not allow – that the required information is provided on the packaging or in the document. accompanying PPE
- Manufacturers must indicate on the PPE and, if this is not possible, on the PPE packaging or on the document accompanying the PPE, their name, registered trade name or registered trademark and postal address at which they can be contacted
- Manufacturers who consider or have reason to believe that the PPE they have placed on the market is not in compliance with this Regulation, immediately take the corrective measures necessary to bring the PPE into conformity, to withdraw it from the market or recall it, as appropriate.
- In addition, where the PPE presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States where the PPE was made available on the market, giving details, in particular, of the non-compliance and of any corrective measures taken.
- Manufacturers shall, further to a reasoned request from a competent national authority, provide all the information and documentation necessary to demonstrate the compliance of the PPE with this Regulation.