BIOCIDES

Review of biocide active ingredients

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.

Fulfilling data requirements

Product evaluation and data gap analysis.
Literature and inventory searching for hazard information on chemical substances (physico-chemical, toxicological, ecotoxicological); assignment of reliability codes to literature data.
Expert reports for ‘data waiving’ arguments.
Advice on testing strategies, tests and laboratories.

Hazard and risk assessment

Calculation of human and environmental exposures during the lifecycle of the active substance (industrial, professional, and consumer use), using exposure scenarios and EUSES software.
Interpretation of physico-chemical, toxicological and ecotoxicological data.
Classification according to EU criteria
Risk assessment

Administrative

Compilation of ‘robust summaries’ from study reports
Dossier preparation in electronic format (eg IUCLID).
Compilation of summary documents
Safety data sheet authoring
Dossier submission and liaison with Authorities

Further information

Biocidal Products Directive – European review of active ingredients

The European Biocidal Products Directive (BPD; 98/8/EC) applies to a wide range of commercial chemical products, such as disinfectants, preservatives, pest control agents, slimicides, and antifouling paints. These products improve efficiency in many industrial processes, and are increasingly used in domestic products, such as antimicrobial washing up liquids and cleansers.
The BPD will gradually supersede the various current national schemes and harmonise the requirements for the registration of biocidal active ingredients and their formulations, reducing barriers to trade, and improving levels of protection of humans and the environment.
Biocides are intended to be toxic, but only to the target organism. Such biologically active chemicals potentially pose a risk to humans and the environment. Hence biocides will become, along with pharmaceuticals and pesticides, one of the most tightly regulated chemical product. That the biocidal product can be used safely is ensured through in-depth regulatory risk assessment, but this is a time-consuming process, which can cause costly delays in marketing.

The deadline for informing the European Commission of existing biocide active ingredients (ie those on the market before 14 May 2000) passed on the 28 March 2002. All active ingredients that do not qualify as existing will be regarded as new, and will have to undergo lengthy regulatory evaluation before being marketed in biocidal products. Hence it was commercially advantageous for industry to ensure their active ingredients qualify as existing, by identifying or notifying their active ingredients (see below). Existing active substances can continue to be marketed while they are evaluated in the review programme.

Scope

The BPD categorises biocidal products into 23 Product Types (PTs):
MAIN GROUP 1: Disinfectants and general biocidal products
PT 1: Human hygiene biocidal products
PT 2: Private area and public health area disinfectants and other biocidal products
PT 3: Veterinary hygiene biocidal products
PT 4: Food and feed area disinfectants
PT 5: Drinking water disinfectants
MAIN GROUP 2: Preservatives
PT 6: In-can preservatives
PT 7: Film preservatives
PT 8: Wood preservatives
PT 9: Fibre, leather, rubber and polymerised materials preservatives
PT 10: Masonry preservatives
PT 11: Preservatives for liquid-cooling and processing systems
PT 12: Slimicides
PT 13: Metalworking-fluid preservatives
MAIN GROUP 3: Pest control
PT 14: Rodenticides
PT 15: Avicides
PT 16: Molluscicides
PT 17: Piscicides
PT 18: Insecticides, acaricides and products to control other arthropods
PT 19: Repellents and attractants
MAIN GROUP 4: Other biocidal products
PT 20: Preservatives for food or feedstocks
PT 21: Antifouling products
PT 22: Embalming and taxidermist fluids
PT 23: Control of other vertebrates

There are still issues regarding which substances are covered by the BPD, and so there is some confusion in deciding which biocide active ingredients should be reported to the Commission. The principle is simple: if the substance is covered by other Directives (eg medicines, cosmetics, plant protection products) then it is not covered by the BPD; conversely, if the substance has biocidal properties, but is not covered by other legislation, then it is controlled under the BPD. In this way, the BPD plugs the hole in a patchwork of chemical product legislation, and prevents a substance being subject to dual regulation for a single use.

However, the borderline between the schemes requires careful delineation, and the Commission has been slow to give comprehensive guidance. Some principles and specific cases illustrate these scope issues of the BPD.

For the borderline with Medicines and Veterinary Medicines the following examples have been published:

Disinfectants used on human and animal skin for general hygiene purpose would be considered to be biocides, providing no therapeutic claims are made. Those intended or demonstrated to have medicinal effects would be considered to be a medicinal product.
Repellents with no killing effects applied to human and animal skin are biocides.
Generally, products used in housing or bedding are biocides, while those used on skin with a therapeutic claim would be medicines.
Biocides used exclusively in in vitro diagnostic medical devices are exempt from the BPD.

For the borderline with Cosmetics, the following decisions are expected to apply:

Cosmetics with secondary biocidal claims (for example a sun cream containing an insect repellent) are controlled as cosmetics.
Preservatives used exclusively in cosmetics are controlled under the Cosmetics Directive (76/768/EEC)

The issue of the registration of articles has been controversial. The UK competent authority expressed reservations regarding authorisation of articles impregnated with biocides, such as mosquito nets, socks, mattress covers, toilet seats and kitchen utensils.

MSs have agreed that articles capable of releasing a biocide comply with the definition of given in the BPD, and should be considered to be a biocidal product

A final issue of scope is the regulation of biocides formed in situ (eg ozone, chlorine and formaldehyde), ie generated by the consumer from chemical precursors by mixing or electrolysis at the point of use. These in fact appear to be outside the definition of biocidal products given in the BPD, as the biocidal product is not supplied to the user in a form intended to be biocidal. However, some MSs have been determined to stop such products slipping through the net.

In situ generated biocides are in general within scope of the BPD, and should be reported to the Commission. This might be difficult where the active ingredient is a complex mixture, or is transient.
Precursors that are also active substances will also have to be reported, but not those that are not active.

Review Programme

The main provisions of the BPD are as follows:

A 10-year review programme to evaluate existing active substances (end of transition period 13 May 2010)
Publication of a list of authorised biocide active substances with their product types as Annex I of the Directive.
National authorisation of biocidal products containing active substances on Annex 1.
Automatic acceptance (mutual recognition) by Member States of biocidal products authorised or registered in other Member States.
Quick authorisation of new products within a frame formulation (ie with only minor changes to an already approved product)

The review programme will assess systematically during a ten-year period all the existing active substances, ie those on the market before 14 May 2000. To qualify, applicants had to give proof that their product was indeed marketed before this date.

The first Review Regulation (1986/200) implements the first phase of the programme to evaluate existing active substances. It established the procedure for obtaining the definitive list of existing active substances, began phase 1 of the full review of the active substances (wood preservatives and rodenticides), and provides a timetable for phasing out unsupported active substances. This Regulation explained how manufacturers or formulators can 'identify' or 'notify' existing active substances for inclusion in the definitive list.

Identification was a simple procedure that allows the biocidal product to be marketed up until 1 September 2006, when the active ingredient was phased out.

Notification allows continued marketing of the active substance until the active substance was either reviewed for Annex 1 listing (continued marketing dependent on outcome of the review), or withdrawn. Note that even if the active substance was notified, if it was not in the required product type, then the product became illegal to market after 1 September 2006.

About 2700 identifications were received for 955 active ingredients; and ca. 570 notifications for 370 substances.

The second Review Regulation (2032/2003) gave the definitive list of existing active substances, ie those that have been successfully identified or notified. This, and the third Review Regulation (1048/2005), describe the systematic review of the rest of the supported existing active substances.

Deadlines for submission of full dossiers for active ingredients are:

Phase 1, 28 March 2004, Product types 8 and 14
Phase 2, 30 April 2006, Product types 16, 18, 19, and 21
Phase 3, 31 July 2007, Product types 1, 2, 3, 4, 5, 6 and 13
Phase 4, 31 October 2008, Product types 7, 9, 10, 11, 12, 15, 17, 20, 22, and 23.

The full dossier includes extensive physico-chemical, toxicological, and ecotoxicological data on the active ingredient (Annexes IIA and IIIA), and also on a representative formulation (Annexes IIB and IIIB). If the data shows that the biocidal product can be used safely, the Commission will enter the active substance in an approved list (Annex I of the BPD). Annex 1 actually comprises three sub-sections:

Annex 1: Any active substance
Annex 1A: Active ingredients for inclusion in low risk biocidal products
Annex 1B: Basic substances

The data requirements for listing of active ingredients in Annexes 1, 1A, and 1B are the same, but registration of products will be simpler for those containing actives in Annex 1A, and no registration is required for products containing actives in Annex 1B. These Annexes will be added to by a few new active substances, but mainly through the evaluation of existing active substances. Annex 1 will restrict the use of the active substance to products in one or more of the 23 product types listed in the BPD. It is important, therefore, that applicants are clear from the beginning which product types are to be supported, as it will be very time consuming to add them later. Certain product types attract additional testing requirements, for both the active ingredient and the biocidal product.

The EU Commission and national Competent Authorities recognised the financial difficulties some niche market industries had in supporting active substances, such as essential oils and pheromones. However, despite intense lobbying, attempts to obtain exemptions or reduced testing packages have failed, and many useful active ingredients have now become illegal to use in biocidal products. After 1 September 2006, over 550 active substances were withdrawn from use in biocidal products.

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