The Authorisation of Biocidal Products in Accordance withThe Biocidal Products Directive(98/8/EC) www.thor.com
Biocidal Products Authorisation • Implementation Process is a two stage vigorous evaluation process: • 1st stage to evaluate active substances which are then placed on Annex I of the BPD if judged to be acceptable for use. • 2nd stage to evaluate Biocidal Products containing those active substances. 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).
National Biocide Legislation • Transitional Arrangements • During the Review Programme any national legislation for biocides in force in Member States is only repealed when the active substance is placed on Annex 1 • The scope and complexity of the legislation varies widely from State to State. For example, a simple listing in Latvia, through to full authorisation process in Poland • Thus it may still be necessary to ensure that a biocidal product has a valid national approval or authorisation • This must be factored into any decisions to move production or introduce products into new market regions
Biocidal Product Authorisation 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
BPD Product Types (PTs) 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)
Biocidal Products Authorisation • What is NOT a Biocidal Product! • A cosmetic preservative • An agricultural pesticide • A detergent where cleaning is the main function • A medical device disinfectant • A therapeutic agent (a drug such as an antibiotic) • (A Treated Article)
Biocidal Products Authorisation 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.”
Initial Manufacturer of the product AS, BP TC Formulator AS, BP TC FP, BP Distributor BP BP BP BP End user ,eg for disinfectant - cleaning company or consumer Biocidal Products Authorisation Routes to market AS = Active Substance; TC = Technical Concentrate; FP = Formulated Product; BP = Biocidal Product
Biocidal Products Authorisation The Authorisation Process • There is only one type of authorisation • Several administrative procedures to achieve it. • Full product authorisation • Frame (Family) product authorisation • Marketing authorisation • Parallel trade authorisation • Provisional authorisation • Experimental authorisation • Emergency authorisation • Authorisations last normally for 10 years • They can be processed through any Member State • They take up to 2 years to process
Biocidal Products Authorisation Mutual Recognition • This process allows an authorisation granted in one MS to be • recognised in another • Can apply either at the authorisation stage or afterwards
Biocidal Products Authorisation 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 For example: 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
The Biocidal Products Regulation(No. 528/2012) www.thor.com
The new Regulation Published on 27 June 2012
The new Regulation • Will become law in September 2013 • Replaces the Directive – with some transitional arrangements • Contains new requirements • “Treated Articles” • In-situ generated biocides • Exclusion criteria • Dual use • Union authorisation • “Family” product authorisation • Free Rider issue • Parallel trade
Treated articles • Definition – • Any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products • If a biocidal claim is made for the article it must be labelled • The label must provide the following information: • Statement that treated article incorporates BP’s • Biocidal property of the treated article • The name of all active substances in the biocidal products • Instructions for use/ precautions because of the biocidal products it incorporates - if this is necessary to protect humans and the environment. • Free consumer information within 45 days • A treated article which has a primary biocidal function shall be considered a biocidal product
Has the substance or mixture a biocidal function? 3. Object is neither a biocidal product nor a treated article Treated 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 Y N 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? N Y Y N 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. Rodent baits, Insecticidal strips
Treated Article Decision Tree 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? N Y 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? Y No prominent claim is made about a biocidal function of the treated article and No public health related claim is made about the treated article. A prominent claim is made about a biocidal function of the treated article or A public health related claim is made about the treated article. N Y N 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).
Labelling Of Treated Articles From: Frequently asked questions on treated articles, prepared by the European Commission (December 2012) 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”)
Exclusion criteria • The following active substances will not be approved (or will be candidates for substitution): • Those classified as Carcinogens, Mutagens or Toxic for Reproduction (Categories 1A and 1B) • Those which meet the criteria for being Persistent, Bioaccumulative and Toxic (PBT) or vPvB • Those with endocrine disrupting properties
Dual use • Biocidal Products intended to be used for the purposes of both the BPR and in connection with medical devices • E.g. a disinfectant used to disinfect surfaces in hospitals and medical devices • Must comply with BPR and the Medical Devices Directive • Cosmetic Products which also make a claim to control microbial growth • E.g. an “Anti-bacterial” liquid hand soap • Although outside the scope of the BPR it is within the definition of a Biocidal Product ( this area is still under active discussion!)
Union authorisation • Single authorisation to remove the need for mutual recognition procedure • Administered by European Chemicals Agency (ECHA) • 1 September 2013 – PT’s 1, 3, 4, 5, 18 and 19; • 1 January 2017 – PT’s 2, 6 and 13 • 1 January 2020, all (except PT’s 14, 15, 17, 20 and 21 if assessment recommends otherwise) • No union authorisation for products containing substances of concern • Fee does not include technical evaluation by CA
Family product authorisation • This replaces the Frame formulation concept and makes it more flexible • Many biocides are variations on the concentration of the active, even the change in colour or fragrance (disinfectants, wood preservatives) • Similar Use (PT) • Same Active Substances • Same/less Risk when changing non-active Substances • No significant reduction in Efficacy • Same hazard classification and safety clauses • Expected to reduce number of authorisations by two thirds and significantly lessen the cost
Free riders • All manufacturers who wish to place an active substance on the market (includes import) must provide ECHA with a copy of the submitted dossier or a letter of access to the dossier as of September 2013 • ECHA will compile a list of manufacturers/importers, and anyone not on that list will not be able to offer their active substance for use in a biocidal product after 1 September 2015 • This will stop non-evaluated actives from being used
Authorisation fees 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
Proposed Fees for Biocidal Product Authorisation in UK 1. Daily rate £392
Proposed fees for Union authorisation 1. Reduced fees: Micro enterprises – 60%; Small enterprises – 40%; Medium enterprises – 20%
For the future? What lies ahead … The Sustainable Use of Biocides • Responsible use: training to professionals; point of sale information; adverse incident reporting; recycling • Authority National Action plans • Incentives for technologies that prevent mis-use, reduce accidents and risk (accelerated reviews, longer approvals) • Obligation on authorities to act against illegal products and illegal uses • Best practise information on all labels & in advertising, responsible uses in sensitive areas.
The REACH Regulation(No. 1907/2006) www.thor.com
REACH – Position regarding biocidal products • Article 15, paragraph 2 of REACH states that active substances notified for the BPD are already regarded as being registered. • This does not include cosmetic preservatives which are outside the scope of the BPD
Issued by www.unece.org Globally Harmonized System of classifcation and labelling of chemicals (GHS)
Implementation of GHS into EU labelling The Dangerous Substance and Dangerous Preparations Directives (both now repealed) • The generic threshold for the labelling of skin sensitisers as Xi, R43 in preparations has been 1% unless a lower limit (Specific Concentration Limit) has been defined. • e.g. CIT/MIT = 0.0015%; BIT = 0.05% • Additionally, since 1999 it has been a requirement in the EU to label all preparations which contain sensitisers at concentrations ≥ 0.1% with the following: • “Contains (name of sensitising substance). May produce an allergic reaction”.
Implementation of GHS into EU labelling 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
Implementation of GHS into EU labelling Generic concentration limits triggering classification of a mixture as a Category 1 skin sensitiser Skin sensitiser Category 1 ≥ 1,0 % (no change) Skin sensitiser Sub-category 1A ≥ 0,1 % !!! Skin sensitiser Sub-category 1B ≥ 1,0 % (no change)
Implementation of GHS into EU labelling Concentration thresholds which trigger the special labelling phrase ‘EUH208’ for components of a mixture Skin sensitiser Category 1 ≥ 0.1 % (no change) Skin sensitiser Sub-category 1A ≥ 0.01 % !!! (= 100ppm) Skin sensitiser Sub-category 1B ≥ 0.1 % (no change) • A SDS is required for the mixture containing a component above this concentration. • For sensitising substances with specific concentration limits lower than 0.1 %, the concentration • threshold should be set at one tenth of the specific concentration limit. • 3. EUH208 — “Contains (name of sensitising substance). May produce an allergic reaction”.
Formaldehyde • Now banned in EU market for use as in-can preservative • Will be reclassified as a Category 1B carcinogen and • Category 2 Mutagen in EU • USA considering the upgrading of HCHO to higher level • HCHO banned or severely restricted in many Eco-label products • Market is responding by removing it from products • Likely to be a “knock-on effect” for formaldehyde donors • Multinational companies are removing it from their global brands • Conclusion – Formaldehyde has no long term future