New penalty provisions introduced for breaches of the EU Biocides Regulation
The German government has closed a pre-existing legislative gap with the First Amendment to the German Chemical Penalties Ordinance (Chemikalien-Sanktionsverordnung – ChemSanktionsV) (Federal Gazette I, p. 951) with respect to penalties. Since 23 April 2016, fines can now also be imposed for breaches of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products.
The EU Biocides Regulation, which has essentially applied in Germany directly since 1 September 2013, contains provisions concerning the approval of active substances and authorisation of biocidal products, as well as their classification, labelling and packaging, and supplemental notification, information, communication and documentation obligations.
Breaches of the directly applicable provisions of the EU Biocides Regulation have to date only been subject to fines to a limited extent, e.g. if companies have breached enforceable orders of competent enforcement authorities. With a new catalogue of penalties included as Section 14 of the German Chemical Penalties Regulation, the option of imposing fines has now also been created for other breaches of the EU Biocides Regulation. The total of 21 fineable offences not only cover the requirements relating to the making available of biocidal products on the market and their use, but also for the first time the provisions for treated articles, i.e. for products which are not themselves to be classified as biocidal products, but which have been treated with, or intentionally incorporate, one or more biocidal products.
Although no separate criminal offences have been anchored in the Chemical Penalties Regulation with respect to the EU Biocides Regulation, unlike the penalties imposed on breaches of Regulation (EC) No 1907/2006 (REACH), heavy fines can result for the companies affected from the catalogue of penalties which has now been created. Penalties for intentional or negligent breaches of the EU Biocides Regulation can be up to EUR 50,000.00 in individual cases (Section 14 Chemical Penalties Regulation in conjunction with Section 26 (1) No. 11 (2) German Chemical Act (Chemikaliengesetz – ChemG)).
In light of these supplementary penalty provisions, companies affected should on their part ensure that any gaps in product compliance for biocidal products and treated articles are promptly closed.
For further questions: Please contact: Martin Ahlhaus
Practice Group: Regulatory & Governmental Affairs; Commerce & Trade