Treated Article or biocidal product - a small difference with huge consequences. Ulrike Frank

Transcription

1 Treated Article or biocidal product - a small difference with huge consequences Ulrike Frank Biocides Symposium 2014, Bratislava, 22./23. May 2014

2 What Is a Treated Article? Definitions: treated article means any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products (Art. 3 (l))?

3 What Is a Biocidal Product? Definitions: Art. 3 (a) biocidal product means any substance or mixture, containing or generating one or more active substances, with the intention of destroying,.. 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.

4 Consequences? A biocidal procuct needs to be authorised, A treated article does not!

5 What is the difference biocidal product/treated article? Primary biocidal function:. A treated article that has a primary biocidal function shall be considered a biocidal product (Art. 3.1 BPR)

6 Biocidal product/treated article? Important document how to interpret the provisions on treated articles: Note for guidance: Frequently asked questions on treated articles CA-Sept13-Doc.5.1.e

7 Biocidal product/treated article? Primary biocidal function: Function is of first rank, importance or value compared to the other functions Criteria: Target species (not harmful for article itself) Concentration of a.s./comparable to a BP Intended use and purpose Identical claim as existing biocidal product?

8 The Rambo Fly Buster is a great option for the horse owner looking to provide the ultimate fly armour for their horse in the summer. This fly sheet is treated with No-Fly Zone Technology to help repel flies in addition to your fly spray. It's made from the same material as the popular Rambo Protector. This unique fabric prevents nicks, rips or tears, yet is soft & absorbent against the horse's body. Imported.

9 Biocidal product/treated article? - Made from unique patented Rambo Protector fabric - Gives freedom of movement and extra protection - Protects sensitive area around dock and top of tail - UV protection - Prevents bleaching of coat - Protects against dirt

10 Biocidal product/treated article? Water filter for tap water.

11 Provisions for Treated Articles All active substances which articles have been treated with or incorporate have to be approved for that Product Type and use (Art. 58(2)) This applies for treated articles when placed on the market in the EU. Transitional period until 1. September 2016/1. September 2017 Complex articles? Supply chain?

12 Provisions for Treated Articles If a claim is made regarding the biocidal properties of the article Labelling obligations:. Biocidal property. Name of all active substances No transitional period!

13 Active Substance Check if the active substance which shall be used to treat an article is already approved for this PT any conditions of approval? Part of the review programme for this PT

14 Active Substance If the active substance is part of the review programme for this PT Check if your use is covered (otherwise update the dossier) If your active substance is not part of the review programme and is not approved A dossier has to be submitted by 1. September 2016 at the latest (otherwise, the article may not be placed on the market after 1 September 2017)

15 Exposure is important!

16 Different Uses/Exposure within PT 9: Fibre, leather, rubber and polymerized materials preservatives Products used for the preservation of fibrous or polymerised materials, such as leather, rubber or paper or textile products by the control of microbiological deterioration. PT 9 This PT includes biocidal products which [ ] hamper or prevent the development of odour [ ].

17 Different Uses/Exposure within PT 7: Film preservatives PT 7 Products used for the preservation of films or coatings by the control of microbial deterioration or algal growth in order to protect the initial properties of the surface of materials or objects such as paints, plastics, sealants, wall adhesives, binders, papers, art works.

18 Exposure categories Area of use Exposure category Example Anti-odour treatment of textiles with skin contact Protection of hard surfaces against infection transmission by splashes e.g. in hospitals Long term dermal contact Short term dermal contact (no food contact) Sport T-shirt, Sleeping bag Tables, trays, worktops Anti-odour treatment of porous surfaces Short-term oral contact Tooth-brush Anti-mold treatment of textiles without skin contact No relevant skin contact Shower-curtain, tarpaulin, awning

19 Global Market Most articles will be treated outside the EU and then be imported. An authorisation of the biocidal product in the EU does not take place The only possiblility for a risk-benefit analysis of the use of these articles is on active substance approval

20 Conditions for approval Article 4: Conditions for approval (of the active substance) [ ] 3. The approval shall specify the following conditions, as appropriate: [.] (d) manner and area of use including, where relevant, use in treated articles;

21 Consequences I Certain uses can be excluded on active substance approval, or Conditions for certain uses in treated articles can be formulated

22 Consequences II If the active substance has properties of particular concern (e.g. CMR, PBT, vpvb, but also skin sensitisers or other particular concerns) even a positive listing of approved uses can be considered See: Note on the principles for taking decisions on the approval of active substances under the BPR (CA-March14-Doc.4.1-final) %20Final%20-%20Principles%20for%20substance%20approval.doc

23 Example: Propiconazole Cited from approval regulation 1) : Where a (treated) article has been treated with or intentionally incorporates propiconazole, and where necessary due to the possibility of skin contact as well as the release of propiconazole under normal conditions of use, the person responsible for placing the treated article on the market shall ensure that the label provides information on the risk of skin sensitisation, as well as the information referred to in the second subparagraph of Article 58(3) of Regulation (EU) No 528/ )

24 First things first Specify your claim! What is the problem you want to solve with a biocidal treatment? Unclear claims and application areas lead to unclear Product Type (PT)-attribution and unclear exposure scenarios. Do you intend to protect the properties of your article? (i.e. prevent damage by (micro)organisms or prolong the lifetime of the article) Or do you intend to add new properties to the article ( hygienic claims ) Attention: can become Biocidal product

25 Guidance Efficacy Assessment of Treated Articles /en/publications/publik ationer/ /

26 What do I have to do? Specify your claim! Communicate up and down the supply chain! Model your exposure scenarios carefully according to application area. Try to categorize them and create exposure envelopes. Create a dossier for PTs and/or uses which are not part of the review programme/of an active substance approval. Update dossiers under the review programme with uses which are not covered.

27 Take home messages Complex articles: Provisions for treated articles apply, (biocidal function is still present in the finished good) If a claim is made, labelling is obligatory: Borderline between treated article/biocidal product difficult Approval is needed for PT and use: Try to cluster uses and to form exposure categories Specify your claim: unclear claims = unclear PT attributions

28 Thank you for your attention!

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30 Guidance Guidance on treated articles a038/CA-Sept13-Doc%205.1.e%20-Final- %20treated%20articles.doc Guidance on Information Requirements: s_guidance_information_requirements_en.pdf Guidance on Risk Assessment of active substances (not yet published)

31 Treated Article or Biocidal Product? Fiber Fiber Biocides additive Biocides additive Active substance Masterbatch containing Biocide Coating Treated article

32 Biocidal Products? Mosquitorepellent

33 Biocidal Products Disinfectant wipes Plug-in mosquito protection

34 Protect properties Supporting a claim In most instances this can be done using typical examples of the materials the treatment is intended for. The untreated material must show the pattern of deterioration that the treatment is intended to prevent in any tests used. Active substance manufacturer often knows about range of applications

35 Add new properties Supporting a claim In most instances this can only be done by the manufacturer of the final article. The need for the treatment must be justified (is there a significant hazard?). Prevents growth do organisms grow under the conditions of use and, if so, does this present a problem? Is the presence of viable microorganisms on the article a significant issue in practice?