New obligation to indicate non-EU companies in the list of biocidal active substances and suppliers [EU]

In a press release issued on 18 August 2014, the European Chemicals Agency (ECHA) announced that, following an agreement with the European Commission (EC), the company names of non-EU entities together with their EU-representatives will be published in the list prepared by ECHA in accordance with Article 95 of Regulation (EU) No 528/2012 of 22 May 2012 concerning the making available on the market and use of biocidal products (the Biocidal Products Regulation). Furthermore, all non-EU manufacturers will have the possibility to appoint an EU representative to fulfil their obligations in relation to the registration of substances, provided by Article 95 of the Biocidal Products Regulation.

As a reminder, ECHA has made publicly available and regularly updated since 1 September 2013 the list of all active substances and substances generating an active substance, for which a dossier has been submitted and accepted or validated by a Member State. This list also includes all persons having made such a submission (Article 95 of the Biocidal Products Regulation).

The term “representative” is not defined by the Biocidal Products Regulation. However, the French helpdesk advises that, in this case, it is appropriate to refer to Regulation (EC) No 1907/2006 of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). According to Article 8 of REACH, the representative is a natural or legal person established within the EU who is appointed by an exporter located outside the EU, in order to fulfil on behalf of the latter, the obligations on importers’ in relation to the registration of substances. Therefore, exporters must inform importers, being in the same supply chain, of the appointment of a representative. In addition, the Article notes that the representative must have sufficient background in the practical handling of substances as well as information related to the substances. The representative also has to make publicly available and regularly update information on quantities imported and clients to whom the substances were sold.

ECHA also announced that the list of approved active substances will include the name of persons not belonging to the EU and participating in the program for the review of all active substances existing on the EU market, which must be completed by 31 December 2024 (Article 89 of the Biocidal Products Regulation). ECHA will contact non-EU companies participating in the Review Programme in order to provide more information about their EU-representatives.

To note, from 1 September 2015, a biocidal product shall no longer be allowed to be placed on the EU market unless the substance supplier or product supplier has been included in the list for the product type to which the product belongs.

As a reminder, Decision 2014/397/EU of 25 June 2014 postponed the expiry date of approval of difethialone and difenacoum (which would have expired on 31 October 2014 and 31 March 2015, respectively) for use in biocidal products for product-type 14 (Rodenticides) to 30 June 2018. Furthermore, Decision 2014/402/EU of 25 June 2014 rejected Germany’s proposal not to authorise for automated dipping the biocidal products containing iodopropynyl butylcarbamate (IPBC) which are listed in the Annex to the Decision.

Red-on-line EHS Legal Counsel

Sources : Press release of the European Chemicals Agency, “Non-EU companies to be indicated in the list of biocidal active substances and suppliers”, ECHA/NA/14/36, 18 August 2014