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FAQ - BIOCIDAL PRODUCTS
 

 

 

FAQ - BIOCIDAL PRODUCTS


What is a biocidal active substance? [1]
 
A biocidal active substance can be:
• one chemical compound with a well-defined structure
• a mixture-by-process of two or more chemical compounds
• an UVCB-substance (substances with Unknown or Variable composition, Complex reaction products orBiological materials)
• microorganisms, such as bacteria, fungi, viruses
• extracts and oils of plants and microorganisms
• fermentation products of microorganisms
with a controlling effect of any harmful organism by chemical or biological means, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect.
 
What is a biocidal product? [2]


A biocidal product can be one or more active substance's) itself or preparation's) of one or more active substance's), e.g. an active substance as an aqueous solution, put up in the form in which they are supplied to the user.
 
What is an existing biocidal active substance and what is a new biocidal active substance? [3]
All biocidal active substances which have been on the EU market before the 14th May 2000 and which have been notified or identified according to the Commission Regulation (EC) No 1896/2000 are considered as existing biocidal active substances. Biocidal active substances which have not been on the EU market before the 14th May 2000 or have not been notified or identified are new biocidal active substances which have to be approved by each Member State according to the Directive 98/8/EC before placing it on the EU market.
 
What is the difference of a notified and an identified existing biocidal active substance? [4]
Notified existing biocidal active substances have been notified according to the requirements of the first review regulation and accepted by the Commission. These notified substances are listed with their intended product types in Annex II of the amended second review regulation (Commission Regulation (EC) 1048/2005). They can stay on the market until it is decided whether or not they are fulfilling the conditions for putting them on the “positive lists” (Annexes I, IA and IB of Directive 98/8/EC).

For identified substances only few data was required during the identification procedure. They can only be placed on the EU market until the 1st September 2006.
 
General questions:


1)  Which are the possible exceptions from the harmonised EU principles for authorisation of biocidal products and on which legal provisions (question relating to avicides, piscicides, mutual recognition) are they based?


Art. 4 (6) of the Biocidal Products Directive (BPD) allows, that “Member States may refuse, subject to the EC Treaty, mutual recognition of authorisations granted for product types 15 (avicides), 17 (piscicides) and 23 (Control of other vertebrates) provided that such a limitation can be justified and does not jeopardise the purpose of the Directive.”
The Austrian Biocidal Products Act does not allow/foresee the authorisation of biocidal products of product types 15, 17 and 23.

2)  What can be reasons to ban or to restrict a biocidal active substance in the EU?
3)  What are the means in the EU to prohibit the purchase and use by the general public of biocidal products containing CMR Cat. 1 or 2 substances?

The restrictions on the marketing and use of certain dangerous substances and preparations according to Directive 76/769/EEC apply directly (Art. 1 (3) a) BPD). E. g. like other (chemical) substances, the marketing for and use of biocidal substances with Category 1 or 2 CMR (carcinogenic, mutagenic, toxic to reproduction) properties by the general public is forbidden
As the appropriate means in the EU to assure this, on the one hand there are the lists of banned/restricted substances in Directive 76/769/EEC, based on the list of all chemical substances with harmonised EU-classification regarding the dangerous properties (Annex I of Directive 67/548/EEC). On the other hand, EU-industry has to appropriately classify and label their substances and products. And thirdly, EU MSs have to support and assure compliance through national inspection and control measures.
For authorisation of biocidal products the BPD furthermore determines that if a product falls under the conditions listed in Art. 5 (2)
“A biocidal product classified according to Article 20(1) as toxic, very toxic or as a category 1 or 2 carcinogen, or as a category 1 or 2 mutagen or classified as toxic for reproduction category 1 or 2, shall not be authorised for marketing to, or use by the general public.”
its use will be restricted to professionals only.
Furthermore, products containing substances with severe eco-toxicological properties, like PBT or vPvB substances, require severe regulations. Certain substances under conventions such as the POPs Transboundary Pollution Convention, posing a very high risk to the environment, are prohibited to be used.

4) Which role is attributed under the EU BPD scheme to WHO classification, LD50 values, concentration limits of content, and exclusion criteria?

Under the EU-BPD scheme these WHO criteria and rules are not applied, which were predominantly developed and designed for harmonisation in the field of plant protection products.
WHO publications and databases, that play a role and are consulted also in the decision finding process for biocidal active substances are confined to the evaluations of carcinogenic substances and activities by the IARC (International Agency for Research on Cancer, http://www.iarc.fr/index.html, in Lyon, France) and the IPCS Intox databank (http://www.intox.org/) which is kept by the WHO in Geneva, Switzerland.
Concerning classification the BPD determines that


o       biocidal substances are classified, packaged and labelled in accordance with the provisions of Directive 67/548/EEC (Dangerous Substances Directive);
o       biocidal products shall be classified in accordance with the provisions relating to classification in Directive  (Dangerous Preparations Directive)
o       biocidal products shall be packaged and labelled in accordance with the provisions relating to packaging and labelling in Directive 1999/45/EC (Dangerous Preparations Directive  and also shall follow the provisions of Art. 20 of the Biocidal Products Directive in addition.
 
5) If a biocidal product, authorised in the country of origin, is imported into an EU MS, does the responsible authority in the import country accept the original dossier (also depending on the similarity/comparability of the data requirements) and the test data therein?

As a basic principle, all test data based on the OECD Guidelines for Testing of Chemicals according to GLP can be used and are acceptable in all OECD countries.
However, the acceptability of a foreign authorisation decision by an EU-MS depends whether the country of origin is also an EU-MS or not:

If the first country, in which the biocidal product was authorised is an EU MS, the general provisions for mutual recognition according to Art. 4 BPD apply; for exceptions see Art. 4 (6).
If the first country, in which the biocidal product was authorised is not an EU MS, the respective decision can only be used to support the decision in the importing EU MS; there is no provision  in the BPD  which states that the authorisation in the country of origin has or ought to be accepted. In any case, the original data and information documents would have to be submitted.    
Member States are required by the BPD to implement the legislation in such a way that biocidal products are authorised/registered according to common EU-principles (Annex VI) after the biocidal active substances which are contained in the biocidal products have been evaluated and included in Annex I/IA of the BPD. A joint data bank with all authorised/registered biocidal products will allow anyone access and a check for a biocidal product in question. The 13th May 2010 is the target date for the finalisation of the review of all existing biocidal active substances and thereby of the transitional period according to Art. 16 BPD.
 
6) What does an authorisation of a biocidal product include; are separate authorisations required for biocidal products to be placed on the market and to be used?

The authorisation is directed in the first instance to allow a biocidal product to be placed on the market, but the conditions of use of this biocidal product are also included in the authorisation decree.
If a product falls under the conditions listed in Art. 5 (2) BPD
“A biocidal product classified according to Article 20(1) as toxic, very toxic or as a category 1 or 2 carcinogen, or as a category 1 or 2 mutagen or classified as toxic for reproduction category 1 or 2, shall not be authorised for marketing to, or use by the general public.”
Its use will be restricted to professionals only.
 
7) Is toxicity testing required for authorisation of biocidal products or can the evaluation be derived from the dangerous properties of the constituents, e. g. by calculation of the LD50 from the substances’-LD50s?

Annex II B of the BPD determines the data requirements for authorisation of biocidal products.
In well reasoned cases, some tests might not be required, the calculation method according to Directive 1999/45/EC (Dangerous Preparations Directive) might – for one or the other dangerous property - be regarded as sufficient; this underlies expert judgement, from case-to-case.
Toxicity tests are not required if an active substance is simply diluted by a solvent (e.g. water).
In most cases the required tests have to be undertaken: Usually, the biocidal products contain 90-99% other substances than the active substance, and most of these substances have not been sufficiently tested themselves.
 
8) Are biocidal active substances regulated under REACH?

There is an agreement under REACH that biocidal active substances are considered registered for their biocidal uses. There is currently no “new” active biocidal substance on the EU market.
Active biocidal substances are regulated and evaluated solely under the BPD for their use(s) in biocidal products. A biocidal active substance will only fall under REACH for other uses, if applicable.
The REACH system, which will come into force probably after 2007, will however, like the current chemicals’ legislation, extent to all other substances in a biocidal product, except the biocidal active substance.
 
9) Will a biocidal product be tested for biological efficacy and evaluated in the framework of the authorisation procedure by each EU-MS?
Prior to authorisation of a biocidal product according to common EU principles the efficacy of each active biocidal substance has to have been shown as a prerequisite for its inclusion into Annex I/IA.
The application dossier for the authorisation of a biocidal product will have also to contain a data package on efficacy (authorisation in the first MS). In case of an application for authorisation by mutual recognition in a second/third MS the required data package will be quite smaller (it will mostly contain summary data); only if the proof is needed in relation to the requirements under Art. 4 (2) of the BPD, new data e.g. on efficacy will be required. If, e. g., unacceptable tolerance or resistance of the target organism to the biocidal product is demonstrated, mutual recognition can be refused. In such a case the EU Commission will be involved (Art. 4 (4) BPD).   
In contrast to the EU Plant Protection Products scheme, which uses the geographical division into four regional zones, no such scheme underlies the authorisation of biocidal products in geographically different located MSs. 
 
10) Is the information on biological efficacy submitted by the applicants considered sufficient by the MS for assuring efficacy?

Under the BPD the information on biological efficacy submitted by the applicants is considered sufficient by the MS in so far as the efficacy tests have been carried out under general quality standards, and their application is certified in the test report. In case of efficacy tests at least the application of the ISO 17025 standard norm is required (see next question/answer).
The task of the authorities is to evaluate the quality standards, completeness, appropriateness, and plausibility of all tests submitted within a dossier. According to Art. 25 BPD the costs arising for authorities from these procedures should be covered by a national fee system. The derived budget is not sufficient that the authorities undertake any additional testing for controlling test data. In case of serious doubt on the quality/correctness of specific test data, they may foresee in their legal provisions that they are allowed in this case to order the repetition of a specific test by an independent laboratory and the subsequent payment by the applicant.
 
11) What are the general requirements for efficacy testing in the EU?

For efficacy testing the BPD in Annex VI specifies:
52. Testing should be carried out according to Community guidelines if these are available and applicable. Where appropriate, other methods can be used as shown in the list below. If relevant acceptable field data exist, these can be used.
—      ISO, CEN or other international standard method
—      national standard method
—      industry standard method (accepted by Member State)
—      individual producer standard method (accepted by Member State)
—      data from the actual development of the biocidal product (accepted by Member State).
There is general agreement among the EU MSs that efficacy testing has to be carried out meeting at least the quality standard of ISO 17025, which allows the mutual recognition of laboratory test data.
OECD had launched a questionnaire to search for available efficacy test methods OECD-wide. More recently, also the European Chemicals Bureau has compiled a list of efficacy test methods accepted in EU-MS; this list is as yet not comprehensive.
The Austrian Competent Authority for Biocides contracts experts with specific knowledge for each of the 23 product types to carry out the evaluation of the efficacy data as part of the application dossiers.
 
12) What are the EU evaluation principles for formaldehyde-releasing biocidal substances?

In the EU Review Programme many disinfectants and preservatives are formaldehyde-releasing substances. Submission of the respective substance dossiers by the different applicants is foreseen for 2007. As it is quite clear that these substances (mostly: precursors) should be treated in the same way, the EU MS are currently developing a recommendation for a harmonised approach for specific data requirements and evaluation.
It is known so far that the formaldehyde-liberation rates will be different and depend to a large degree on the use conditions. Therefore, difficulties in testing are anticipated concerning the differentiation between systemic and local toxicity.
 
13) How to treat a claim of non-toxicity to humans, animals etc?

Such a claim is not permitted according to the provisions for labelling in Art. 20 (3) BPD and according to the restrictions on advertising in Art. 22 (2) BPD.
 
14) Is labelling and advertising on a repellent “for the use on baby skin” allowed?

The EU provisions for labelling and advertising are more general and do not mention this example or a similar case explicitly, but a biocidal product must neither be claimed as harmless, nor must the message be misleading.
It would be subject to the outcome of a risk assessment, respectively the safety factors, whether a simple indication on the label could be given that the use on baby skin is possible.
 
15) What are the EU provisions concerning the shape of containments and the limitations of volume for insecticides?

The general rules in the BPD for biocidal products containments are listed in Art. 20 (2):
“Biocidal products shall be packaged in accordance with Art. 9 of Directive 1999/45/EC. In addition:
(a) products which may be mistaken for food, drink or feeding stuff shall be packaged to minimize the likelihood of such a mistake being made;
(b) products available to the general public which may be mistaken for food, drink or feeding stuff shall contain components to discourage their consumption.”
Furthermore, independent on the product type, an applicant for authorisation of a biocidal product has to submit data that prove that the product does not react with the container material (Annex IIB, also for the biocidal substance, Annex IIA).
Art. 20 (2) (a) demands that special care is attributed to the packaging volume and material, which are subjects of the product authorisation conditions.
 
16) Which principles apply in environmental effects / risk assessment if tested environmental organisms show diverging LC/EC/LD50 values?

While Annexes IIA and IIB list the data requirements for biocidal active substances and biocidal products, for environmental effects/risk assessment the general principles of the EU Technical Guidance Document on Risk Assessment (TGD), Part II, Chapter 3, Environmental Risk Assessment, apply. The respective TGD is accessible from the European Chemicals Bureau Homepage underhttp://ecb.jrc.it/Documents/TECHNICAL_GUIDANCE_DOCUMENT/EDITION_2/tgdpart2_2ed.pdf.

Quotation from Chapter 3, Effects Assessment, p. 93, therein:
“… This means that for each of the… compartments a PNEC has to be derived. A PNEC is regarded as a concentration below which an unacceptable effect will most likely not occur. In principle, the PNEC is calculated by dividing the lowest short-term L(E)C50 or long-term NOEC value by an appropriate assessment factor. The assessment factors reflect the degree of uncertainty in extrapolation from laboratory toxicity test data for a limited number of species to the 'real' environment. Assessment factors applied for long-term tests are smaller as the uncertainty of the extrapolation from laboratory data to the natural environment is reduced.”
Further on, a detailed guidance is given on the interpretation of studies relevant for risk assessment (e. g. most sensitive species, long-term tests), etc., and on page 101, the appropriate assessment factor, dependent on the data package, can be deduced.
 
Scope and borderline questions:
 
17) How can it be understood that a biocidal active substance can also be, e. g., an agricultural pesticidal active substance, a substance covered by the Medical Devices Directive and/or the Medical Products Directive?
18) If a product is covered by more than one Directive, which Directive’s authorisation/registration provisions apply?

Some Products can contain the same active substance and still be covered by different Directives, because the decisive issue is the intended use of the product, which determines the regulatory scope.

In the EU, a product for general disinfection in hospitals would be covered by the BPD. Only disinfectants for disinfection of specific medical devices - in conjunction of which they are then often sold - belong to the scope of Directive 93/42/EEC on Medical Devices. It is, however, possible, that such a product due to a general and a specific use is covered by both directives, and will then have to be authorised/registered according to both directives’ provisions.
Many products which currently are on the Turkish market and are used in hospital hygiene are registered as medical devices, like disinfectants for walls. There is new TR regulation that clarifies that general disinfectants cannot be defined as medicinal products or medicial devices.
 
19) Are feeding stuffs or food stuffs, like honey and beer in insecticide traps, covered by the BPD?

This case is explained in the Manual of Decisions, e. g. under point
“2.5.9.2. Sticky traps containing attractants
…Food and feedstuffs are not generally excluded (from the BPD), as no relevant Directive is mentioned in…Article 1 (2) of the BPD. When they are used in attractants and repellents, the intention is not to feed but to control the effects of harmful organisms. In a pragmatic approach, food and feedstuffs used as co-formulants in biocidal products could be considered as substances of no concern, whereas, when they are used as active substances they will have to be evaluated taking into account waiving possibilities as referred to in Article 8(5) of the BPD. It states that “information, which is not necessary owing to the nature of the biocidal product or of its proposed uses need not be supplied. The same applies where it is not scientifically possible to supply the information.” (That means that such food/feeding stuffs usually will not have to be evaluated.)
Sticky traps without attractants are not covered by the BPD as the controlling effect is not by chemical or biological means.”
 
20) Are ultrasonic and electrocution devices for fighting insects covered by the BPD?

Ultrasonic and electrocution devices are not covered by the BPD as the controlling effect is not exerted by chemical or biological means.
 
21) Are insecticides used in dog houses against fleas covered by the BPD?

If a product is used to treat dog houses against fleas it is a biocidal product. If a product is used on animal skin, e.g. for repelling fleas etc., it would normally be a biocidal product and be covered by the BPD, but not necessarily: If, e. g., the product is intended to be used on animal skin which is not intact, it is a veterinary medicinal product.
To assist in such a borderline decision, the Manual of Decisions describes similar cases.
 
22) Are products for use to protect plants or plant products in warehouses from pests regarded as plant protection products or biocidal products?

Products which are used to fight pests of stored plant products, like plant mites in agricultural warehouses in human settlement areas are usually regarded as plant protection products, in particular if used on plant products.
 
23) Are repellents applied to the human skin medicinal or biocidal products?

In the EU, repellents which are used on human skin to repel e. g. insects are usually considered biocidal products, contrary to Turkey, where they are considered at the moment as medicinal products. Furthermore, the active repellent substances in question are included in the 2nd Review Regulation (Reg. No. 2032/2003, amended by Reg. No 1048/2005).
In contrast to repellents, and as agreed in the Guidance Document on the borderline between medicinal products and biocidal products, and described as a case in the Manual of Decisions, point 2.1.2.1., in the EU ectoparasiticides on animals and humans, anti-lice shampoos are considered human medicinal products as they  treat  the illness pediculosis.
 
24) Is a sun lotion containing a repellent but without a repellent claim a biocidal product or a cosmetic product? What about other products with minor repellent effects?
The case of a sun lotion with sun protecting but also repellent properties is described in the Manual of Decisions, point 2.1.3.1, Cosmetic Product / Biocidal Product.
In general, it depends on the primary function of the product. If it is intended to have a biocidal - in this case repellent -effect, this is reflected by the concentration of the biocidal substance in the product. In case that the concentration is efficacious the biocidal claim should be made; the product has in any case to be authorised/registered under the BPD.
Products which have primary a disinfectant property but also a repellent property should normally be authorised under the BPD (for examples see Manual of Decisions, chapter 7.1., Tables with examples of borderline cases).
 
25) Is a paper tissue with a hygienic and minor disinfectant claim a biocidal product?
In general, the tissue should be tested for its disinfectant effect. If it is active, it should be authorised/registered under the BPD.
In general, products with anti-bacterial and disinfectant properties are under the scope of Product Type 1. Exemptions depend on the intended use of the product.
For case descriptions see Manual of Decisions, point 2.5.1.1., Anti-viral paper tissues, chapter 3.1., Treated articles and import of such articles, and chapter 7.1., Tables with examples of borderline cases.
 
26)  Where is the borderline between wood preservatives falling under the PPPD or the BPD?

The description in Annex V of the BPD of Product type 8, wood preservatives, is “Products for the preservation of wood, from and including the saw-mill stage, or wood products by the control of wood-destroying or wood-disfiguring organisms".
Therefore, a wood preservative used in the forest on trees or on cut wood with the bark not removed, is a plant protection product. A wood preservative used to preserve cut wood without bark in a saw mill, or wood to be used for furniture, is a biocidal product.
 
27) Under which conditions is no authorisation needed in the EU for biocidal products containing in-can preservatives?

If an active substance has only an internal preserving action, namely to protect the content (in-can) but not the material treated afterwards with the product (by an external action), no authorisation of the biocidal product is required. However, the preserving active substance itself, and the formulation containing it to be added to the product to preserve it, are covered by the BPD.

A paint controlling wood fungi (external effect) is a biocidal product requiring authorisation or registration.

Treated end materials (e.g. treated with active substances of PTs 7 or 11) and these active substances themselves are only covered if they are produced in the EU, if the product is imported from a non EU Member States they are not covered by BPD. Only in case imported treated end materials exert or claim an external biocidal effect, they are covered by the provisions of the BPD.

 

 

 

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