Compliance with REACH (European Chemicals Regulation) and legislation relating to Biocides continues to present challenges for businesses. Our 10 top tips are designed to help you focus on key compliance areas, whether you are manufacturing in or importing into the EEA, or based outside the EEA and supplying into the EEA.
1. Are your REACH registrations/pre-registrations held by the correct group company i.e. the company which is the manufacturer or “importer” for REACH purposes?
If not, you are not REACH compliant. It may be possible for you to re-organise your internal supply chain making one entity clearly the importer and then transferring product to other entities in the same group. Alternatively it may be possible to transfer REACH registrations/pre-registrations through a ‘legal entity change’. This requires careful consideration, to assess whether your situation can qualify as a “legal entity change”, and if so how this should be documented.
2. If you are based outside the EEA, are you entitled to appoint an Only Representative (“OR”)?
Only a person established outside the EEA who manufactures a substance on its own or in a mixture, or formulates a mixture or produces an article which is then imported into the EEA can appoint an OR. There have been occasions where a REACH regulator in the EEA has taken enforcement action where an OR was wrongly appointed, and requested ECHA to delete the REACH pre-registrations which had been made by that OR.
3. What about a REACH audit? Are you ready to respond to enquiries from regulators regarding your REACH compliance (including Safety Data Sheet (“SDS”) and extended SDS?
REACH audits are an increasing part of the regulatory landscape in the EEA. A REACH audit protocol is essential to ensure that key information is assembled quickly and efficiently.
REACH requires manufacturers and importers, downstream users and distributors to retain all relevant information to carry out REACH duties for 10 years from the last date of manufacture, import, supply or use of the substance or product. This information has to be made available without delay on request of any EEA regulator in any Member State in which you are established or to ECHA. Do you have systems in place to provide this information quickly?
4. Are you prepared for the final REACH registration deadline (2018)?
Many more companies will be required to register the substances they manufacture/import into the EEA. Now is the time to be thinking about whether you will need to register, whether you will join a SIEF and what data access you will need.
5. REACH also applies to articles (e.g. clothing, electronics, furniture)
REACH registration is not generally required for substance in articles, however, there are other obligations where an article contains a Substance of Very High Concern. The list of Substances of Very High Concern can be found on ECHA’s website and is updated regularly. The distinction between an article and a substance/mixture is not always straightforward and may merit a legal opinion.
6. Do you supply or use a biocidal product, or an article treated with a biocidal product in the EEA? If so, is the active substance in it approved by the European Commission or is it included in the Review Programme, in each case in the Product Type applicable to your use?
Generally, if the active substance is not, it cannot be used in biocidal products or articles treated with biocidal products in the EEA. There are however some transitional provisions which enable products to remain on the market in some circumstances for a limited period where they contain an unapproved active substance.
If your active substance is still in the Review Programme do you know how long it will take to come through the Review Programme, and the timescales for applying for product approval for the Product Type applicable to your use?
7. Where do you source your biocidal products from – inside or outside the EEA Member State in which you are placing them on the market?
While the active substance remains in the Review Programme you have the challenge of complying with the national law of the EEA Member State in which you are placing a product containing it on the market. Requirements vary depending upon whether you are sourcing that biocidal product from inside or outside that EEA Member State. Depending on the circumstances, your local entity may need its own approval or registration under that national law.
Once the active substance is approved by the European Commission, you will be able to apply either for Union wide approval, or obtain approval in each relevant Member State for the Product Type applicable to your use.
8. Is your supplier on the Article 95 list of active substances and suppliers?
From September 2015, a biocidal product cannot be supplied for distribution or use in the EEA unless the active substance supplier or biocidal product supplier is on the approved list in the Product Type applicable to your use. This Article 95 list is on the ECHA website and it is expected to be updated regularly.
You need to check that someone in your supply chain is listed. You should keep a copy of this updated list since EEA regulators expect to see a compliance audit trail. Any breach would be subject to national enforcement and so would vary across the EEA.
9. Are you aware that the biocidal products regime extends to imported goods and materials treated with biocidal products (“treated articles”)?
Obligations are imposed on manufacturers, importers and suppliers of biocidal products and goods treated with biocidal products in certain circumstances. Articles can only be treated with active substances approved by the European Commission or which are subject to the Review Programme for the Product Type applicable to your use. In addition there are labelling requirements when a biocidal claim is made or as a condition of approval of the active substance. There is also an obligation to provide information following a consumer’s request. Transitional provisions apply in some circumstances meaning that articles treated with non-approved active substances may continue to be placed on the EEA market.
10. REACH may also be applicable to biocidal products
Don’t forget that only the active substance in the product is exempt from REACH. Any other ingredients should be checked for REACH compliance.