Regulatory compliance for chemical, cosmetic and biocidal products.
BIOCIDES
Registration of biocidal products
Services
Alchemy Compliance can provide consultancy in the area of the Biocidal Products Directive, with a broad experience in chemical supply legislation (classification, risk assessment, etc.), and regulatory chemistry, toxicology, and ecotoxicology. We can advise on biocidal product registrations in the UK, Ireland, the Netherlands, and Belgium, and other Member States and territories on request.
Fulfilling data requirements
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Product evaluation and data gap analysis.
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Literature and inventory searching for hazard information on chemical substances (physico-chemical, toxicological, ecotoxicological); assignment of reliability codes to literature data.
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Expert reports for ‘data waiving’ arguments.
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Advice on testing strategies, tests and laboratories.
Hazard and risk assessment
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Calculation of human and environmental exposures during the lifecycle of the active substance (industrial, professional, and consumer use), using exposure scenarios and EUSES software.
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Interpretation of physico-chemical, toxicological and ecotoxicological data.
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Classification according to EU criteria
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Risk assessment
Administrative
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Compilation of ‘robust summaries’ from study reports
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Dossier preparation in electronic format (eg IUCLID).
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Compilation of summary documents
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Safety data sheet authoring
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Dossier submission and liaison with Authorities
Further information
Authorisation procedures for biocidal products
Biocidal Products Directive (BPD; 98/8/EC)
The existing national provisions continue to operate for the authorisation of existing formulations, and new formulations containing existing active substances, until the Commission makes a decision on whether to include that active substance in Annex I of the BPD. Existing active ingredients or their uses not supported through the BPD review programme will be phased out.
Once the active substance is included in Annex 1, the biocidal products require authorisation by the individual Member States. Full authorisation for the product may only be granted if the active substance is listed in Annex I for the particular product type.
The data requirements for the biocidal product depend on which part of Annex 1 the active ingredient is listed: authorisation of products with an active ingredient in Annex 1; a simpler registration of products for those containing actives in Annex 1A; and no registration is required for products containing actives in Annex 1B.
Further data requirements are required for certain Product Types (PTs). The data requirements are given for the active ingredient in Annexes IIA and IIIA, and for the formulation in Annexes IIB and IIIB. A biocidal product application requires information on both the active ingredient and the formulation. Applicants can use a Letter of Access to fulfil data requirements (particularly for the active ingredient), whereby a previous applicant gives permission for a subsequent applicant to use their data in support of the product authorisation.
The principles for product evaluation are based on Articles 3 and 8, and the Common Principles in Annex VI of BPD. Product authorisations will be subject to mutual recognition [Article 4(1)], ie a biocidal product that has already been authorised or registered in one Member State shall also be authorised by further MSs, unless there are strong grounds for not doing so.
National Schemes
UK
Non-agricultural pesticides are currently regulated in Great Britain under the Control of Pesticides Regulations 1986 (as amended) (COPR) and require approval before they can be advertised, sold, supplied, stored or used.
Scope of COPR
Non-Agricultural Pesticides regulated by the Health and Safety Executive (HSE) under the COPR are:
Algaecides (for non-plant protection purposes only): Products used for the control of algae and blanket weed in ponds and lakes (including home garden/ornamental).
Antifouling products: Products applied to the hulls of boats and ships, oilrigs, fishnets, fish farming equipment and other man made structures to prevent the growth of algae, seaweed, mussels and barnacles.
Avicides/Bird stupefying agents: Products used for the control of nuisance/pest bird such as feral pigeons and starlings.
Biocidal paints: Products painted onto internal surfaces such as ceilings and walls to prevent growth of fungi, mould and algae.
Insect repellents: Products used to repel insect pests by making a particular site or food source unattractive.
Insect repellents applied to animals: Products applied directly to animals to repel nuisance insects (NB insect repellents for use on human skin are not within the scope of COPR).
Insecticides: Products used for the control of insect pests, which are either a public health concern (eg. cockroaches) or a nuisance (eg. ants).
Molluscides: Products used for the control of slugs and snails.
Rodenticides: Products used for the control of rats and mice.
Surface biocides: Products used to remove or prevent undesirable growth such as moss, lichen, mould or mildew on external and internal surfaces. They are applied to masonry, brickwork, tiles etc.
Vertebrate repellents: Products used to repel vertebrates such as cats and dogs from fouling in and around domestic gardens.
Wood preservatives: Products which penetrate into wood in order to protect the wood from natural predators such as beetles, and wet and dry rot.
Wood treatments: Products painted onto the surface of wood in order to protect it against surface staining or fungi.
The data required for the authorisation depends on the regulatory status of the active ingredient. The data consists of a core set for all biocidal products, with additional data according to the type of produts and its use category. Data requirements can be fulilled either by providing study reports, or by a Letter of Access. A guidance document for applicants is available: Non-Agricultural Pesticides Registraton Handbook.
Ireland
Legislation
The Pesticide Control Service (PCS) of the Department of Agriculture and Food is the competent authority for the implementation of the biocides legislation in Ireland. Directive 98/8/EC is given effect in Irish law by Statutory Instrument S.I. No. 625 of 2001.
This Irish legislation requires that all biocides (using the EU BPD definition) on the market in Ireland must be notified to the PCS using the required notification form. The notification form provides basic information on the nature, composition and intended uses of a biocide. This notification is a transitional measure, which will allow the products concerned to remain on the market pending completion of the EC biocides review programme specified in the BPD.
It is the responsibility of the company that markets a biocide in Ireland to ensure that the product is notified to the PCS in accordance with S.I. No. 625, either by themselves or by another company acting on their behalf. Data can be treated as confidential if companies so indicate.
All of the costs associated with the implementation of the legislation will be eventually be borne by the biocides industry. However, no blanket charges are being levied on industry during the initial notification phase for 'existing' biocides. Existing biocides are defined as those on the market in Ireland prior to the 1st of February 2002 and new biocides are those not on the Irish market prior to that date. Applications for notification of a new biocide are subject to a fee (currently €254).
Netherlands
The Dutch use a definition of a biocide similar to that provided in the BPD, and the processes for obtaining national authorisation of a biocidal product are similar to those that will be required in other MSs under the BPD. Applications for authorisation are submitted to the CTB using the appropriate forms.
The CTB have a Helpdesk, which can be consulted for information about dossier requirements, application procedure, and a cost estimate for the application to be submitted. The Helpdesk will provide support for applications for authorisation of biocidal products.
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