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EU Biocides : Regulation (EU) No 528/2012 & Subsequent amendments
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EU Biocides : Regulation (EU) No 528/2012 & Subsequent amendments
Brief Summary
The Biocidal Products Regulation [BPR, Regulation (EU) 528/2012] concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product.
Regulation (EU) 528/2012 repeals the Biocidal Products Directive (BPD, Directive 98/8/EC) and aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment.
To place a biocidal product on the EU market, an authorization shall be granted by the competent authorities and the active substances contained in the biocidal product shall be approved.
The Regulation sets out rules for:
• Approving active substances in biocidal products
• Authorising the supply and use of biocidal products
• The supply of articles treated with biocidal products
The Regulation also includes provisions to reduce animal testing by making data sharing on vertebrate studies compulsory, and encouraging a more flexible and intelligent approach to testing.
Terminology under EU Biocides
Biocidal product :
Means:
— any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action,
— any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.
Micro-organism :
Means any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including lower fungi, viruses, bacteria, yeasts, moulds, algae, protozoa and microscopic parasitic helminths.
Active substance :
Means a substance or a micro-organism that has an action on or against harmful organisms.
Existing active substance :
Means a substance which was on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product and process-orientated research and development.
Residue :
Means a substance present in or on products of plant or animal origin, water resources, drinking water, food, feed or elsewhere in the environment and resulting from the use of a biocidal product, including such a substance’s metabolites, breakdown or reaction products.
Nanomaterial :
Means a natural or manufactured active substance or non-active substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm.
Use :
Means all operations carried out with a biocidal product, including storage, handling, mixing and application, except any such operation carried out with a view to exporting the biocidal product or the treated article outside the Union.
Letter of access :
Means an original document, signed by the data owner or its representative, which states that the data may be used for the benefit of a third party by competent authorities, the Agency, or the Commission for the purposes of this Regulation.
Authorisation :
Means national authorisation, Union authorisation or authorisation in accordance with Article 26.
National authorisation :
Means an administrative act by which the competent authority of a Member State authorises the making available on the market and the use of a biocidal product or a biocidal product family in its territory or in a part thereof.
Union authorisation :
Means an administrative act by which the Commission authorises the making available on the market and the use of a biocidal product or a biocidal product family in the territory of the Union or in a part thereof.
Technical equivalence :
Means similarity, as regards the chemical composition and hazard profile, of a substance produced either from a source different to the reference source, or from the reference source but following a change to the manufacturing process and/or manufacturing location, compared to the substance of the reference source in respect of which the initial risk assessment was carried out, as established in Article 54.
Administrative change :
Means an amendment of an existing authorisation of a purely administrative nature involving no change to the properties or efficacy of the biocidal product or biocidal product family.
Minor change :
Means an amendment of an existing authorisation that is not of a purely administrative nature and requires only a limited re-assessment of the properties or efficacy of the biocidal product or biocidal product family.
The Agency :
Means the European Chemicals Agency established by Regulation (EC) No 1907/2006.
More definitions ...
Link: EU Biocides definitions.
Our Regulatory Services on EU Biocides
Service Pack 01: EU Biocides Proxy Services
- ¤ Third Party Representative for EU Manufacturers, or EU Importers
- ¤ Acting as Third Party Representative when undertaking the technical work with the European Chemicals Agency and EU Competent Authorities
- ¤ Handling of all communication with the European Chemicals Agency and/or Competent Authorities
- ¤ Single contact point process across multiple EU States
- ¤ Monitoring of relevant regulatory developments (including proposals, policies and adopted laws)
- ¤ Assistance for meeting legal requirements for the archival and retrieval of the product (BPR Article 68)
- ¤ Full biocides Helpdesk Support
Service Pack 02: EU Biocides Technical Modular Services
- ¤ Status verification for all active substances
- ¤ Strategic planning for the biocidal products authorisation process
- ¤ Generation of new active substance approval dossier
- ¤ Generation of biocidal product dossier for National and Union Authorisation
- ¤ Generation of biocidal product dossier for Mutual recognition of an authorisation (Concurrent and sequential procedures)
- ¤ Submission of applications via R4BP portal and follow-up of the dossier
- ¤ Submission of applications for authorisation modifications (administrative change, minor and major change)
- ¤ Preparation and submission of application for inclusion in Article 95 List of active substances’ suppliers
- ¤ Assistance and preparation of biocidal products dossiers to comply with national transitional measures
- ¤ Post submission support (addressing queries / requests for additional information from the European Chemicals Agency and/or Competent Authorities)
- ¤ Generation of biocidal products safety data sheets and labelling
- ¤ Renewal of authorisation applications