From the 21st April 2018, Council Directive 89/686/EC will be replaced by Regulation (EU) 2016/425, relating to Personal Protective Equipment (PPE). The impact that this will have on end users, such as yourselves, is that the EC Type examination certificates will only be valid for a period of 5 years, meaning that those in the supply chain will have to continually review PPE products and produce improved ones where necessary. This will help to decrease illegal and counterfeit products, as well as remove older products from the market, guaranteeing the PPE you purchase is safer to use than ever before.
This includes the addition of several classes of PPE, as well as the reclassification of others, meaning it now covers the whole of the supply chain, on top of the manufacturing link. The general health and safety requirement is that all protection must be adequate against the risks for which it is designed to protect wearers against.
In the new regulations, PPE means:
- Equipment which has been specially designed and manufactured for the purpose of protecting the wearer against risks to personal health and safety.
- Any interchangeable components for equipment which are essential to the protective function the equipment it is designed for.
- Connexion systems for equipment that is not worn or held by a user which is designed to connect equipment to either a reliable anchorage point, or external device, but which is not designed to be permanently fixed or fastened before commencing work.
This new regulation covers the manufacturers, importers and distributors of Personal Protective Equipment. Each has a series of steps they must follow.
For manufacturers, when placing PPE on the market they must ensure, amongst other things, that:
- Each importer places their name (including their registered trading name) or trademark, as well as the postal address at which they may be contacted. Exceptions will be made in cases where the nature or the size of the equipment does not allow for PPE. For example, this includes situations where the importer would be required to open packaging in order to place this information.
- PPE is accompanied with either a copy of the EU declaration of conformity, or an internet address where the relevant documents may be viewed.
- Any manufacturer who believes that the PPE they have placed on the market does not conform with the regulations must immediately take corrective measures to bring the PPE in question into conformity and withdraw or recall any equipment which does not meet the PPE regulations.
The new regulations which have placed conformities on importers of PPE as well including:
- Checking that the manufacturer has drawn up all technical documents and that the PPE carries the CE marking and is accompanied with all relevant documents.
- Ensuring that all of the correct conformity assessment procedures have been completed by the manufacturer.
- If it is believed that the PPE which they have placed on the market is non-conformal, the importer must take all corrective measures to ensure that the PPE conforms, or withdraw and recall any items as appropriate.
- The importer must keep a copy of the EU declaration of conformity of all PPE items placed on the market for a period of 10 years.
- Any further requests for information from a National Authority must be provided by the importer which demonstrates that the PPE conforms, and it must be in a language that is understandable by that National Authority.
The responsibilities of the PPE legislation which covers distributors include requirements:
- To ensure that before a product is available on the PPE market, they verify that the CE mark is visible and accompanied with instructions in a language which may be easily understood by the relevant end-user.
- To ensure that during the time that the PPE is in their responsibility, it will not be damaged or jeopardised by any transport methods or storage conditions.
- To ensure that if they have any reason to believe that the PPE which they have made available onto the market does not conform to the new regulations, that they withdraw/recall it from the market.
- If they believe the PPE presents a risk, that they inform the National Authority immediately giving all available details, especially the particulars around the non-conformity of the PPE and any corrective measures taken.
When the new regulations come into effect on the 21st April 2018, there will be a two-year transition period for all member states and notified bodies in order to prepare for the introduction of the new regulation. Full details of Regulation (EU) 2016/425 are available here.
If you have any queries regarding PPE then give THSP a call on 03456 122 144, or visit www.thsp.co.uk.