Brussels, 17 July 2012
Questions and Answers on the new Biocides Regulation
The new regulation on the use and placing on the market of biocidal products will repeal and replace the current directive on biocides (98/8/EC). It will enter into force on 17 July 2012. The date of applicability of the Regulation is 1 September 2013.
What are biocidal products?
Biocidal products are used against harmful organisms such as pests and bacteria. They include household products such as disinfectants, rodenticides, repellents, and insecticides. Others are used in more industrial applications as wood and material preservatives, anti-fouling paints, and embalming products.
Biocidal products are used to control organisms that are harmful to human or animal health, or cause damage to natural or manufactured products. Due to their intrinsic properties and uses, such products may themselves pose health risks and be harmful to the environment. It is vital therefore to ensure that only biocidal products safe for use are placed on the market.
Biocidal products contain or generate active substances which act against harmful organisms.
What are the aims of the new Regulation?
The objective of the new Regulation is to improve the functioning of the internal market in biocidal products whilst ensuring a high level of environmental and human health protection. The new Regulation will also remedy a number of weaknesses that were identified during the 11 years of implementation of the current Directive 98/8/EC.
The new text simplifies and streamlines the requirements for approving active substances and authorizing products. The new provisions will also reduce animal testing by making data sharing compulsory and encouraging a more flexible and intelligent approach to testing. A dedicated IT platform (the Register for Biocidal Products) will be used for submitting applications as well as recording decisions and disseminating information to the public. The new Regulation is also the first piece of legislation to build in the new Commission definition on nanomaterials.
The text is also a major breakthrough for the internal market with the creation of a Union authorisation of biocidal products, which will allow industry to directly place their products on the entire Union market.
What are the main differences between the new regulation and the previous one?
The Regulation concerning the placing on the market and use of biocidal products will repeal and replace Directive 98/8/EC.
The current Directive establishes a two-step process of approval:
1) evaluation of the active substance at the Union level, and
2) product authorisation at Member State level.
The Regulation will maintain this two-step approach while providing for the possibility that some biocidal products are authorised at the Union level giving them direct access to the entire Union market.
What are the key features of the new Regulation?
Provide for the authorisation at the Union level of certain biocidal products;
Improve the functioning of national authorisations and mutual recognition by introducing binding deadlines and strengthening the system of mutual recognition dispute settlement;
Reduce the number of animal tests by obligatory data sharing with respect to vertebrate animal studies;
Strengthen the rules on data waiving (i.e. not request data which is not necessary);
Extend the scope to cover articles and materials treated with biocidal products (e.g. furniture treated with wood preservatives), which are imported from third countries;
Harmonised fee structure which will harmonise the conditions and criteria for setting the fees in all Member States;
The European Chemicals Agency (ECHA) will be involved in the scientific work on biocides;
Persons placing biocidal products on the market will have to hold the data on active substances (before they are obliged to do so under the product authorisation application).
What are the implications for ECHA, the chemicals agency?
The European Chemicals Agency (ECHA) will provide a strong scientific and technical back-up to the Commission and the Member States under this new Regulation. 100 persons will eventually work on biocides related activities for a total annual budget of 25 Mion EUR.
ECHA will in particular be responsible for the assessment of applications for the Union authorisation of biocidal products.
The total number of opinions to be delivered by ECHA is expected to grow from 80 in 2014 to 300 in 2020. The new regulation will retain the two-step authorisation process brought in by the current directive, whereby active substances are first tested and approved and included in a Community list, with subsequent authorisation of a product containing the active substance.
What are the savings for industry?
The impact assessment foresees cost savings for the European industry of ca. €2.7 billion over a period of 10 years.
What will this mean for animal testing?
Although the new Regulation will not ban animal testing completely, it attempts to minimise it as far as possible. It introduces an obligation to share data on vertebrate animal tests in exchange for fair compensation, and a prohibition to duplicate such tests. This is expected to save both costs and animal lives.
The new Regulation also encourages data-sharing for non-animal tests, with a similar view to reducing the overall costs of the legislation to the industry and avoiding the duplication of efforts. The data sharing process will be administered by the European Chemicals Agency (ECHA), in consultation with applicants.
Under the new Regulation, applicants may consult with a Member State Competent Authority regarding their proposal for data requirements and in particular any proposed animal testing. In addition, Member States have to inform and if possible assist applicants with adaptation requests to data requirements.
The new Regulation also changes the rules concerning core data requirements. Under the current directive, the same set of data must be submitted for all biocidal products, not all of which is always necessary. The new Regulation establishes a more systematic approach to the waiving of data requirements.
The grounds for data waiving provided for in REACH will apply. In practice, this means that data should be submitted to support a risk assessment only when necessary. It also means that the Regulation recognises that there are situations when data requirements can be addressed by means other than testing on animals and when human or environmental exposures are so low that additional data doesn't necessarily increase the ability to manage risk. Certain long-term animal studies, for instance, will only be required when necessary. These are the most costly data requirements, both financially and in terms of lives of test animals
The Regulation introduces specific and general rules for the adaptation of data requirements. These rules should be considered in conjunction with the core and additional data when preparing the initial information requirement proposal. As regards general adaptation rules, testing may be waived if it's not deemed necessary, as the required information may be provided using: existing data or weight of evidence; QSAR; in-vitro methods; or grouping or read across approaches. Testing that is not scientifically possible or based on reduced exposure can also be waived.
European Commission: http://ec.europa.eu/environment/biocides/index.htm