Market outlook: Reach compliance – 10 top tips for EEA biocides

Compliance with Europe’s Reach (Registration, Evaluation, Authorisation and Restriction of 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 European Economic Area (EEA), or based outside the EEA and supplying into the area.

Some eight years after Reach was introduced, and two-thirds of the way through the phased implementation, many businesses are still struggling with a number of its complexities.

1. Are your Reach registrations/pre-registrations held by the correct group company, meaning the company that is the manufacturer or “importer” for the purposes of Reach?

If not, you are not Reach-compliant. It may be possible for you to reorganise 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 first whether your situation can qualify, 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 that 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 the European Chemicals Agency (ECHA) to delete the Reach pre-registrations that 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 can be 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 upon request to 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 Substance Information Exchange Forum (SIEF) and what data access you will need.

5. Reach also applies to articles (eg clothing, electronics, furniture)

Reach registration is not generally required for substances 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 that 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 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 – 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 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 articles treated with non-approved active substances may continue to be placed on the EEA market.

10. Reach may also apply to biocidal products

Do not forget that only the active substance in the product is exempt from Reach. Any other ingredients should be checked for Reach compliance. As 2018 looms we are expecting a wide range of SMEs to have to get to grips with Reach in detail for the first time, and this will be challenging for many. However, our experience suggests that even larger companies with registrations already in place would in many cases benefit from reviewing their compliance position. If there are issues to be addressed, whether in relation to Reach or biocides, one is likely to get a more favourable reception from a regulator if those issues are addressed now, rather than some time down the line.

Elizabeth Shepherd is head of environment at Eversheds law firm, which combines local market knowledge and access with the specialisms, resources and international capability of one of the world’s largest law firms. www.eversheds.com