A Practical Guide to Biocidal Products and Articles

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1 A Practical Guide to Biocidal Products and Articles Version 2.0 February 2017 Prepared by FIRA International

2 Contents Introduction... 3 A quick step by step guide to help you meet EU Biocides Regulations for NBF Code of Practice... 4 The Regulations... 5 Importing a Treated Article... 6 Placing a Biocidal Product on the Market... 6 Placing a Treated Article on the Market... 7 Labelling... 7 Who should label... 8 Achieving compliance... 9 Products without Biocides... 9 Due Diligence GENERAL ADVICE Competent Authority Enforcement Appendix A Resources Websites Regulation Appendix B Glossary P a g e

3 Introduction This document has been prepared to assist you in your understanding of the Biocidal Products Registration regulations and how you fit into those regulations This document does not replace any legislative documents that are available and is simply additional information to help guide you to achieve compliance. We recommend that you review and monitor the regulation(s) and standards, details of which can be found at the end of this document Version 2.0 FEBRUARY

4 A quick step by step guide to help you meet EU Biocides Regulations for NBF Code of Practice Ensure you are aware of the EU Biocides Regulations and how they impact on your company. Check your range of products and identify any that contain biocidal products to protect against bed bugs, bed mites, fungus woodworm etc. If any biocidal product is found, open a file on it and determine if it is imported either as a complete product or component from outside the EU or from within the EU. Contact your supplier and obtain from them details of the chemical/biocide (active substance) used to protect. Also certification of approval and use type. Ensure that your product is labelled in accordance with the regulations. This is a new requirement for the NBF Code of Practice and as such will only be given a nonconformance if there is no awareness of these regulations. Version 2.0 FEBRUARY

5 The Regulations The Biocidal Product Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms, like pests or bacteria, by the action of the active substances contained in the biocidal product. The BPR replaces as of the 01 st September 2013 the Biocidal Product Directive Like other European regulation the BPR uses articles to define key points and the requirements required to achieve compliance. Article 3 defines a biocidal product as: any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action: or any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action. A treated article that has a primary biocidal function shall be considered a biocidal product. Article 3 defines a treated article as: any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products In our industry we do not yet have any members of whom manufacture a Biocidal Product, but do import treated articles into the EU due to this this guide will cover both Biocidal Products and Treated Articles Version 2.0 FEBRUARY

6 Importing a Treated Article Importing a Treated article into the EU is classed as Placing a Product On the Market, therefore you must ensure treated articles you place on the market comply with the requirements of the BPR before you commence importing. This is a significant change from the Biocidal Product Directive which allowed articles to be imported that could be treated with substances not allowed in the EU For Manufactures and Suppliers who do not import from outside the EU you may progress to Placing a Treated Article on the Market Placing a Biocidal Product on the Market As described above, if you intend on importing into the EU a treated article whether claiming Biocidal properties or not you must treat the article as if it were a Biocidal Product. This means you will need to do the following: Check the status of the active chemical If your active substance is not; o Approved for Product Type o Under review for your product type o Listed in the Annex 1 of the EU BPR (List of active substances that can be used in products that qualify for the simplified authorisation procedure) Then you cannot place the active substance on the market at this time. In our case you could not import an article with an active substance that fails to meet the above If your active substance fails to meet the above then you will need to take one of two routes to be able to bring the article in to the EU: Support your substance through the active assessment and approval process or 1 Submit an application to Amend Annex I of the BPR and gain authorisation for the product 1 If the active substance has been approved for the product type then you need to get your product authorised before you can place it on the market, you will need to decide if you need National Authorisation for example you only intend to sell in the UK or Union Authorisation. You must submit this application on ECHA s website. 2 1 For more information on Registering substances either for active assessment or to Amend Annex 1 of the BPR please visit the ECHA website. They have guidance on preparing your dossier 2 The HSE website offers a detailed guide to registering you product. Information can be found here Version 2.0 FEBRUARY

7 Placing a Treated Article on the Market If you are not importing an article containing a Biocidal Product and you do not manufacture biocidal products for use in your own products then the following applies to you: Treated articles are defined as any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products Articles can range from simple to complex pieces. Articles are affected even if only one component of the article contains a biocide such as preservative in the wooden frame of a divan base Article 58 of the BPR outlines your responsibilities to the regulations, below is a list of requirements Your Article must contain Biocidal Products that have been registered and have an active substance that is approved for use and with the correct product type approval Manufactures or Importers may have to include specific information about the treated articles they place on the market Suppliers of Treated Articles must provide, free of charge when requested, information on the biocidal treatment of the treated article. This information must be provided within 45 days Labelling How you label the article depends on the type of claim you are making about the article. For example if you want to claim the biocidal properties of a mattress then you must label the article in accordance with Article 58 of the regulation See below graphic I supply and market a mattress with Anti-Allergy and claim biocidal properties A) A statement that the product incorporates biocidal products B) The biocidal property attributed to the product C) The name of all the active substances contained in the biocidal products D) The name of all nanomaterials contained in the Biocidal Product, followed by the word Nano in brackets E) Any relevant instructions for use, including any precautions to be taken because of the biocidal products with which a treated article was treated or which it incorporates Version 2.0 FEBRUARY

8 I supply a Divan with a preservative treatment in the timber but we do not claim biocidal properties on the product Regardless of claim being made or not, or if the approval conditions of the biocide stipulate, Manufacturers and Importers must label the article with any relevant instruction for use, including precautions to be taken if this is necessary to protect Humans, Animals or the Environment* *This is extracted from the HSE website and is the current UK CA take on the regulation Who should label The simple answer is the first person to place that Article on the market, but as a manufacture of Divan bases for example, and if the timber you purchased to make the divan had a claimed biocidal property, then the labelling details must pass on. Therefore you would need to take the labelling information from the timber label and move it on with the product. For clarity around labelling and the current UK understanding of this section of Article 58: The current UK understanding of the labelling requirement is that the person first placing the treated article on the market must label it in accordance with the requirements and these labelling requirements do not apply to anyone who subsequently makes available on the market that same treated article but if you take a treated article and incorporate it into a more complex article (using preserved wood in the frame of a sofa for example) then the company placing that complex article on the market may need to meet any necessary labelling requirements 3 3 Reference HSE Website - Version 2.0 FEBRUARY

9 Achieving compliance As above to achieve compliance depends on if you import Treated Articles (Either as Component or Finished Article) from outside of the EU or manufacture inside the EU using treated articles also sourced within the EU. The below table outlines the required actions and if your route to market is applicable: Imported Treated Action EU Treated Article Article Check Active Substance Approval Status No If Active Substance not Approved then either: Active Substance Approval or No Application to amend Annex 1 BPR if applicable If your substance is gains approval or is already approved for type and use then you must have the No product authorised for use Check Biocidal Product for approval and use type No Biocidal Claim made on treated article, full label required (Article 58) No Biocidal Claim made on treated article, label required if necessary protect to Human, Animal or Environment Information of biocidal treatment to be provided free of charge and within 45 days if requested Products without Biocides If you manufacture/import products which you believe have no Biocidal properties then you have no actions to follow in these regulations. However it would be a good idea to periodically check with suppliers especially timber suppliers to guarantee no biocides in your supply. If you do discover that there are biocides in you product but no claim made by the manufacturer then follow the various steps in this guide to help you achieve compliance Version 2.0 FEBRUARY

10 Due Diligence As with REACH the competent authority in the UK, The HSE, will if requested need to see your proof of compliance, i.e. diligence. It s important that you have a good diligence system and as REACH a good purchasing policy. If you only source from EU suppliers of treated article then its good practice to build good relationships. If you import from outside of the UK then you will need to know your supplier well and you will need full specifications and risk assessments As a minimum we advise the following as diligence required: Purchasing Policy Risk Assessments MSDS for all active substances (If Importing) Records of registration steps taken, including screenshots, copies of dossiers etc. (If Importing) from the manufacture you will need to obtain and keep the following: o o o safety data sheets and specifications of active substances and other ingredients used for manufacturing the biocidal product records of the various manufacturing operations performed; results of internal quality controls; o identification of production batches (If EU) Records of diligence checks for Product Status and Use, including screenshots etc. Your product specification, including bill of materials Records of any information requests If you import Treated Articles into the EU then your records must be kept for a minimum of 10 years in accordance with the requirement for Biocidal Products For EU treated articles there is no specific guidance but 6 years minimum would seem acceptable as with other regulation Version 2.0 FEBRUARY

11 GENERAL ADVICE There are some circumstances where a Biocidal Product can be used whilst awaiting approval. This is listed in Transitional Measures, and a result of active substance having been approved under the old Biocidal Products Directive. However should this active substance fail to gain approval under the Regulation then you have a duty to remove it from the market 4. Competent Authority 5 HSE is the UK Competent Authority (CA) for biocides under the EU Biocides Regulation (EU BPR) and we are able to deal with enquiries that are relevant to our role as the UK Competent Authority (CA). We can advise those applicants/companies who: Are supporting active substances through the biocides review programme where the UK is the Rapporteur Member State (RMS) Have products (or are about to place them) on the UK market. Have paid the General Industry Charge (GIC) or are acting on behalf of those companies that have paid. Enforcement 6 EU Biocides Regulation 528/2012 (EU BPR) The EU Biocides Regulation 528/2012 (EU BPR) are enforced under the HASWA, by virtue of Regulation 8 (1) of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013 (BPC). The BPC regulation defines the application of the Act, including enforcement powers, offences, and the allocation of enforcement responsibilities. Enforcement of the use of biocidal products is split between the HSE and local authorities, in-line with the Health and Safety (Enforcing Authority) Regulations 1998 (SI 1998 No 494). If the incident involves Advertisement or retail sale of Biocides It should be reported to Your local trading standards office which can be found on the Trading Standards Central website All issues arising from the use of Biocidal products HSE or your Local Authority. You can find out who is the appropriate enforcing authority from the HSE website Should you require any further information, or if in any doubt, please seek further advice and guidance from:- NATIONAL BED FEDERATION TEL: For more information on Transition Measures see Reference HSE Website Reference HSE Website - Version 2.0 FEBRUARY

12 Appendix A Resources Websites ECHA - The HSE - Regulation Biocidal Product Regulation (BPR, Regulation (EU) 528/2012) - Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations Version 2.0 FEBRUARY

13 Appendix B Glossary For a full glossary of terms for Biocidal Product Regulation visit the HSE website. Active ingredient The active component or mix in a formulation that confers the efficacy of a product. Initially a COPR term, but is now often used as a synonym to ' active substance'. Active substance Defined by the EU BPR (Regulation 528/2012) as "A substance or micro-organism that has an action on or against harmful organisms Biocidal product Defined by the EU BPR (Regulation 528/2012) as " Any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action. Any substance or mixture generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical means. A treated article that has a primary biocidal function shall be considered a biocidal product." Treated article Any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products. Version 2.0 FEBRUARY

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