The Authorisation of Biocidal Products in Accordance with The Biocidal Products Directive (98/8/EC). www.thor.com. Biocidal Products Authorisation. Implementation Process is a two stage vigorous evaluation process:
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Because there is a large number of actives to be evaluated the process is being phased over a 14 year period, known as The Review Programme (completion for 2014 – this now seems unlikely. Will be revised to 2025).
Definition of a Biocidal Product
“Active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or
otherwise exert a controlling effect on any harmful organism by chemical or biological means.”
The European Court Of Justice has recently ruled that the concept of biocidal product must be interpreted as
"including even products which act only by indirect means on the target harmful organisms, so long as they contain one or more active substances provoking a chemical or biological action which forms an integral part of a causal chain, the objective of which is to produce an inhibiting effect in relation to those organisms.“
!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! This would now include flocculants for microbes
Group 1 – Disinfectants & general biocidal products
PT1 – Human hygiene products
PT2 – Private and public area disinfectants
PT3 – Veterinary hygiene products
PT4 – Food & feed area disinfectants
PT5 – Drinking water disinfectants
Group 2 – Preservatives
PT6 – In-can preservatives
PT7 – Film preservatives
PT8 – Wood preservatives
PT9 – Fibre, leather & polymer preservatives
PT10 – Masonry preservatives
PT11 – Liquid cooling & processing preservatives
PT12 – Slimicides
PT13 – Metal-working preservatives
Group 3 – Pest control (PT14 – 19)
Group 4 – Other biocidal products (PT20 -23)
(includes antifouling & embalming)
Who is responsible for obtaining an Authorisation?
“Application for authorisation shall be made by, or on behalf of, the person who will be responsible for the first placing on the market of a biocidal product in a particular Member State and shall be to the competent authority of that Member State. Every applicant shall be required to have a permanent office within the Community.”
Placing on the Market:
“Any supply, whether in return for payment or free of charge, or subsequent storage other than storage followed by consignment from the customs territory of the Community or disposal. Importation of a biocidal product into the customs territory of the Community shall be deemed to constitute placing on the market for the purposes of this Directive.”
End user ,eg for disinfectant - cleaning company or consumerBiocidal Products Authorisation
Routes to market
AS = Active Substance; TC = Technical Concentrate; FP = Formulated Product; BP = Biocidal Product
The Authorisation Process
When do you have to apply for authorisation?
Within 2 years after the date when the last of all the active substances in your product has been placed on Annex 1 of the Directive for the PT application for that product
Your biocidal product is a PT2 disinfectant which contains glutaraldehyde, benzalkonium chloride and ethanol
Listings dates* on Annex 1 for PT2 as follows:
Glutaraldehyde – 3 April 2010
Benzalkonium chloride – 10 September 2009
Ethanol – 6 July 2012
Application must be made after 6 July 2012 and before 5 July 2014
* All dates are fictitious and for illustration only
27 June 2012
Has the substance or mixture a biocidal function?
3. Object is neither a biocidal product nor a treated articleTreated Article Decision Tree
Does the object meet the definition of an article as given in REACH?
The object is then an article as defined under REACH
The object is then a substance or a mixture as defined under REACH
Has the substance or mixture been treated with or intentionally incorporates one or more biocidal products?
Has the substance or mixture a biocidal function?
1. Biocidal product
2. Treated article
3. Object is neither a biocidal product nor a treated article
Mixtures (such as paints, etc.) containing an in-can preservative, treated wood, treated paper pulp.
4. Object is neither a biocidal product nor a treated article
The object is an article as defined under REACH
Has the article been treated with or intentionally incorporate one or more biocidal products?
Does the treatment or incorporation confer a biocidal functionto the treated article?
Does the treatment or incorporation confer a primary biocidal function to the treated article?
No prominent claim is made about a biocidal function of the treated article
No public health related claim is made about the treated article.
A prominent claim is made about a biocidal function of the treated article
A public health related claim is made about the treated article.
5. Treated article
6. Biocidal product
7. Treated article
Articles with a primary biocidal function (e.g. toilet seat disinfecting wipes, insecticide-impregnated bed net, articles claiming an antibacterial action)
Articles with no primary biocidal function (articles preventing the growth of odour-causing bacteria such as socks, articles, such as refrigerators or plastic containers, with antimicrobial linings)
Articles with no biocidal function (e.g. wooden-treated furniture).
From: Frequently asked questions on treated articles, prepared by the European Commission
Question: In Article 58(3)(c) of BPR, what does 'all active substances contained in the biocidal products' mean?
Proposed Answer: This is to be understood as all active substances which contribute to the biocidal properties targeted by the claim, or for which the conditions of approval so require.
As an example, if a claim is made regarding the biocidal property of treated wood (e.g. long-lasting wood protection against insects), the name of the active substance acting as wood preservative and contained in the biocidal product would have to appear on the labelling of the treated article, but not the name of any in-can preservative contained in the biocidal product.
 This interpretation could be seen as being at odds with the previous one. However, the objectives of 58(2) and 58(3) are not the same: In the first case the objective is to protect public and animal health and the environment from non-approved active substances, which thus justifies a wider interpretation. However, in the second case, the objective is to allow consumers to make informed choices when a claim is made about the biocidal properties of a treated article. In addition, it would be disproportionate to require information about active substances other than those that triggered the labelling requirement in the first place, i.e. those which contribute to the biocidal properties or for which the conditions of approval so require.
This interpretation is still under discussion as there is no legal difference between active substances which form part
of the claim and those which provide an “internal” effect (so-called “silent preservatives”)
For full authorisation of a Biocidal Product
* Based on fee schedules published by Member States. Some fees are minimum costs. Does not include Mutual recognition, annual administration fees or dossier preparation costs
1. Daily rate £392
1. Reduced fees: Micro enterprises – 60%; Small enterprises – 40%; Medium enterprises – 20%
What lies ahead …
The Sustainable Use of Biocides
Globally Harmonized System of classifcation and labelling of chemicals (GHS)
The Dangerous Substance and Dangerous Preparations Directives (both now repealed)
2nd ATP to CLP Regulation
Substances shall be classified as skin sensitisers in accordance with the following criteria:
Category 1: Substances where data are not sufficient for sub-categorisation in accordance with the following criteria:
(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or
(b) if there are positive results from an appropriate animal test
Sub-category 1A: Substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have the potential to produce significant sensitisation in humans. Severity of reaction may also be considered.
Sub-category 1B: Substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals can be presumed to have the potential to produce sensitisation in humans. Severity of reaction may also be considered
Generic concentration limits triggering classification of a mixture as a Category 1 skin sensitiser
Category 1 ≥ 1,0 % (no change)
Sub-category 1A ≥ 0,1 % !!!
Sub-category 1B ≥ 1,0 % (no change)
Concentration thresholds which trigger the special
labelling phrase ‘EUH208’ for components of a mixture
Category 1 ≥ 0.1 % (no change)
Sub-category 1A ≥ 0.01 % !!! (= 100ppm)
Sub-category 1B ≥ 0.1 % (no change)