10/30/2014

Obelis SA Obelis European Authorized Representative Center

New Biocide regulation amended by EC

On the 11th of March 2014, Regulation (EU) 334/2014 amending the NEW Biocide Regulation (EU) 528/2012 was published on the official journal of the European Union. The amendment was primarily intended to provide clarifications on the transitional measures between the former Directive (BPD 98/8/EC) and the NEW Regulation.


Why was (EU) 528/2012 amended?


A phase out provision was missing in the original text of the 528/2012 Regulation (published on May 22nd 2012 and came into force as of September 1st 2013). This meant that there was no period to allow existing stocks of biocidal products which did not comply with the new requirements to be exhausted.


Regulation 334/2014 rectified this situation by the correcting Article 52:


‘Notwithstanding Article 89, where the competent authority or, in the case of a biocidal product authorised at Union level, the Commission, cancels or amends an authorisation or decides not to renew it, it shall grant a period of grace for the making available on the market and use of existing stocks, except in cases where continued making available on the market or use of the biocidal product would constitute an unacceptable risk to human health, animal health or the environment. The period of grace shall not exceed 180 days for the making available on the market and an additional maximum period of 180 days for the use of existing stocks of the biocidal products concerned.’


Impact on Cosmetic products


Annex V of the Biocide Regulation presents the Biocidal product types. The first group of product types is disinfectants (Main Group 1). Within this group, the first product type is products intended for personal hygiene – meaning, products intended to come in contact with the skin with the primary intention of disinfecting. Cosmetic products can (by their virtues and characteristics) fall under this product type and as such, require to be regulated as Biocides rather than as Cosmetics – in which case, compliance with the EC 1223/2009 will be replaced by compliance with Regulation (EU) 528/2012.


Biocide Regulation – Process to EU Market


Regulation (EU) 528/2012 is aimed at regulating products intended to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of an active substance(s) contained in the product. The Regulation aims to simplify the approval process of active substances and the authorization of products.


As in the 98/8/EC Directive, the approval of active substances takes place at Union level while the subsequent authorisation of the biocidal products takes place at Member State level. This authorisation can be extended to other Member States by mutual recognitions. The novelty of the (EU) 525/2012 Regulation in this regards, is the possibility of a new type of authorisation at Union level, thus reducing the administrative burden of the product authorization on a Member state level.


Specific online platforms (e.g.: R4BP 3 & IUCLID 5) have been created towards submitting applications and sharing data and information between the applicants, the European Commission, the EU Member state authorities and the European Chemical Agency.


The European Chemical Agency


The European Chemical Agency (ECHA) has a facilitating and coordinating role under the Biocide Regulation.


The European Chemical Agency (ECHA) shall play a Coordinating role with respect to the approval process of active substances and the Union authorization. Companies may apply for the approval or the inclusion in Annex I of an active substance by submitting a dossier to ECHA and companies wishing to apply for an EU-wide authorisation in one go (Union authorization) may do so through the ECHA services. ECHA also offers technical and scientific support to the Member States, guidance and a helpdesk support.


If you would like to know more on the Biocide Regulation, please contact us.