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New EU Regulation on “Personal Protective Equipment” Imposes Stringent Requirements on Manufacturers and Importers

On 31 March 2016, the Official Journal published Regulation 2016/425 on personal protective equipment (PPE). The new Regulation will repeal the previous law, namely, Council Directive 89/686/EEC, once the Regulation fully enters into effect. Its provisions are intended to continually ensure the protection of health and safety of users of personal protective equipment in the EU.

The Regulation defines PPE as 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. It also includes interchangeable components and connexion systems for said PPE. 

In general, examples of PPE that may be relevant to Hong Kong’s exporting community include sunglasses, other types of eye protection, prescription lenses, hard hats and other headgear, special purpose shoes and other types of footwear, protective gloves, protective clothing, life jackets, high visibility vests and seasonal clothing.

The new Regulation does not apply to all types of PPE. The Regulation excludes PPE specifically designed for use by the armed forces, the maintenance of law and self-defence (with the exception of PPE intended for sporting activities). Additionally, the Regulation does not include PPE designed for private use to protect against atmospheric conditions that are not of an extreme nature and from damp and water during dishwashing.

The PPE Regulation, which will have to be uniformly applied EU-wide, is mandatory. Hong Kong traders involved in the production of PPE exported to and distributed on the European Union market must ensure that their products comply with the new Regulation.

The Regulation sets out specific requirements for manufacturers, importers, distributors, authorised representatives and economic operators. Hong Kong sellers of PPE who intend to sell their products on the EU market should familiarise themselves with the obligations of, especially, manufacturers and importers, set out in Articles 8 and 9 of the Regulation, to ensure that their products meet the respective requirements. In short, manufacturers are required to:

  • ensure that their products meet the essential health and safety requirements set out in Annex II of the Regulation that apply to them;
  • draw up the technical documentation referred to in Annex III;
  • carry out the applicable conformity assessment procedure or have it carried out;
  • draw up the EU declaration of conformity;
  • affix the CE marking in accordance with the Regulation;
  • indicate, on the PPE, their name, registered trade name or registered trade mark and the postal address at which they can be contacted;
  • ensure that the PPE bears a type, batch or serial number or other element allowing its identification; and
  • prepare and supply instructions to accompany the PPE; the instructions must include the name and address of the manufacturer and an internet address where the EU declaration of conformity can be accessed. However, an internet address does not need to be contained in the instructions if the EU declaration of conformity accompanies the PPE.

Manufacturers are obliged to keep the technical documentation and the EU declaration of conformity for 10 years after the PPE has been placed on the market.

As for importers, they are obliged to place only PPE that is compliant with the Regulation on the EU market. Importers are required to ensure that the manufacturer has completed or complies with the following obligations:

  • the conformity assessment procedure;
  • preparation of the technical documentation;
  • affixing of the CE marking;
  • accompaniment of the PPE by the required documents;
  • affixing of a type, batch or serial number;
  • affixing of the manufacturer’s name, registered trade name or registered trade mark and the postal address; and
  • accompaniment of the PPE by the instructions and information set out in Annex II.

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.

Importers shall, for 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.

Importers shall ensure that, while the PPE is under their responsibility, storage or transport conditions, they do not jeopardise its conformity with the applicable essential health and safety requirements set out in Annex II.

Where an importer 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 place it on the market until it has been brought into conformity. 

If the PPE presents a risk, importers shall immediately inform the competent national 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.

If a Member State discovers that a PPE product on the EU market is in breach of the new Regulation, it will first ask the relevant economic operator to put an end to the non-compliance. However, where non-compliance persists, in accordance with Article 41 of the Regulation, the Member State shall take all appropriate measures to restrict or prohibit the PPE being made available on the market or ensure that it is recalled or withdrawn from the market.

Additionally, Article 45 of the Regulation allows Member States to implement national penalties for non-compliance. There is, therefore, a strong incentive for traders of PPE to ensure that their products are in full compliance.

The new Regulation will apply from 21 April 2018 (with the exception of only a few provisions which will apply before then; see Article 48). On 21 April 2018, old Directive 89/686/EEC will be repealed.

Importantly, Member States are not allowed to 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. Moreover, EC type-examination certificates and approval decisions issued under Directive 89/686/EEC shall remain valid until 21 April 2023, unless they expire before that date.

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