1. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 1 REPUBLIC OF SLOVENIA MINISTRY OF HEALTH CHEMICALS OFFICE OF THE REPUBLIC OF SLOVENIA Transitional measures of Active Substances, Biocidal Products, Treated Articles, Borderline between new Cosmetic Regulation and new Biocidal Regulation Vesna Ternifi www.uk.gov.si Workshop on Biocidal Products Regulation and practices INT MARKT 52198 Ankara, 6 - 7 June 2013

2. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 2 Introduction Specifics of transitional measures –Active substances –Biocidal products –Treated articles Borderline between new Cosmetic Regulation and new Biocidal Regulation Conclusions Content

3. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 3 Why transitional measures? BPD BPR

4. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 4 Transitional measures Chapter XVII on Final provisions Articles 89 to 95 of the BPR

5. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 5 Transitional measures Active substances Biocidal products Treated articles

6. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 6 BPR Art. 86 – substances included in Annex I BPD shall be included in the list of approved substances Art. 89 (1) – continuation of the work programme on evaluation of existing a.s. under Dir. 98/8/EC Art. 90 – continuation of the review programme, new responsibility of ECHA Art. 95 – access to the a.s. dossier Active substances

7. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 7 Art. 89 (1) – Review programme COM shall be empowered to adopt delegated acts that concern: –carrying out of the work programme –rights and obligations of CA and applicants –extension of the duration of the work programme extended to 31 December 2024 Active substances

8. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 8 Article 90 – Continuation of review programme ECHA shall be responsible for the co-ordination of the evaluation process and provision of organizational and technical support for CA and COM for: –A.s. dossiers submitted after 1 September 2013 –A.s. dossiers submitted under BPD from 1 January 2014 Active substances

9. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 9 Article 90 – Continuation of review programme a.s. dossiers not submitted in accordance with Art. 11(2) of the BPD by 1 September 2013 shall be evaluated in accordance with BPR or Reg. 1451/2007 where concerns identified under provisions of the BPR additional data shall be requested Active substances

10. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 10 Article 95 – access to the a.s. dossier From 1 September 2013 any person placing a.s. on its own or in biocidal product shall submit to ECHA: –A.s. dossier or –Letter of access (LoA) or –Reference to an a.s. dossier where data protection has expired This article only relates to Category 6 of Annex I of the BPR LoA can be used by a 3 rd party for product authorisation Active substances CHANGE

11. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 11 Data sharing, compensation, protection: –all tox. and ecotox. studies + any tox. and ecotox. studies not involving tests on vertebrates –as a derogation from Art 60 on data protection these end for a.s. not yet approved under BPR on 31 December 2025 List of a.s. sources will be published by ECHA If the a.s. is not in the list of a.s. sources, a BP shall not be made available on the market as of 1 September 2015 Disposal and use of existing stocks of BP may continue until 1 September 2016 Article 95 – access to the a.s. dossier CHANGE

12. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 12 Biocidal Product Regulation Art. 89 (2), (3) & (4) – continuation of national system of approval, authorisation procedures and phase-out for biocidal products (BP) Art. 91 - applications for BP submitted under BPD Art. 92 – BP authorised/registered under BPD Art. 93 – BP not in scope of BPD Biocidal Products

13. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 13 Art. 89 (2), (3) & (4) MS can continue to apply national system of approval until 2 years after the approval of the last a.s. contained in BP in case of a decision of not approved a.s. biocidal product can be available on the market for up to 12 months after such decision outlines transitional procedures from national to BPR authorisation procedures –Submission of applications –non-submission of applications (in 180 days or 365 days of the market) phase-out for biocidal products MS reject the application or not to grant the authorisaton: 180 days after rejection shall BP no longer be available on the market 365 days after rejection can disposal and use of existing stocks continue Biocidal Products CHANGE (2) (3) (4)

14. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 14 Art. 91 - applications for BP submitted under BPD but not evaluated until 1 September 2013 shall continue to be evaluated under BPD, unless –1 or more criteria under Art 5(1) is met for a.s. –1 or more criteria under Art 10 is met for a.s. Biocidal Products authorisation under Art. 19 BPR authorisation under Art. 23 BPR applicant can submit additional information

15. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 15 Art. 92 – BP authorised/registered under BPD before 1 September 2013 Remain available on the market and used subject to the conditions stipulated under BPD until expiry of the authorisation/registration BPR shall also apply to biocidal products from 1 September 2013 Biocidal Products

16. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 16 Art. 93 – Biocidal product not in scope of BPD Products available on the market on 1 September 2013 must submit application for authorisation at latest by 1 September 2017. Art. 17 derogations: –Allows continuation on market until the date of decison granting the authorisation, if an application was submitted –Provides phase-out periods where authorisation refused or non-submission of application (180 days after) Biocidal Products CHANGE

17. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 17 Biocidal Product Regulation - Art. 94 An application for approval of an a.s. contained in TA has to be submitted until 1 September 2016 in order that TA available on the market on 1 September 2013 may continue to be placed on the market ? Phase out periods also provided from 1 September 2016, where there is: –a decision not to approve a.s. for the relevant PT (180 days after) –Or of 1 September 2016 if no application submitted Treated Articles CHANGE

18. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 18 Art. 86 – provisions apply for all a.s. from Annex I BPD – approval date should be the date of inclusion Art. 89 (2) –extension of deadlines for granting, modification and cancellation of product authorisation to 3 years –current national system to existing a.s. (combination of existing and non-existing a.s.) can be applied for BP until existing a.s. has been approved and products are hence eligible for authorisation Draft Commission proposal to amend Regulation (EU) No 528/2012

19. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 19 Art 89(4) – provides phase out periods –the same periods should apply for products already placed on the market where an authorisation is granted but conditions of the authorisation require the product to be changed Art 93 (2) – article 17 derogations –applies only subject to MS national rules Art 94(1) – TA may continue to be placed on the market –Until 180 days after 1 September 2016 or –For TA containing only 89(2) a.s. or… until the date of approval for the relevant PT and use of the last a.s. contained in BP in TA or; in case of not approved a.s. for the relevant use, until 180 days after such decision Draft Commission proposal to amend Regulation (EU) No 528/2012

20. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 20 Art. 95 Prescribes the submission of a complete dossier, cost compensation, data sharing and data protection List published by ECHA shall contain the names of participants in the work programme, and all relevant substances with submitted dossier As of 1 September 2013 any supplier not yet on the list wishing to place on the Union market shall submit a complete substance dossier Biocidal products containing a.s., for which relevant persons are not included in the list are prohibited for placing on the market Disposal and use of existing stocks of BP may continue until 1 September 2016 or until 1 year after the inclusion of the a.s. in the list Draft Commission proposal to amend Regulation (EU) No 528/2012

21. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 21 Transitional measures help and show how to move from old to the new legislative regimes Articles 89 - 95 cover transitional measures for active substances, biocidal products and treated articles Correction of errors - ongoing procedure Summary

22. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 22 Borderline between new Cosmetic Regulation and new Biocidal Regulation

23. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 23 Cosmetic Regulation (EC) 1232/2009 (CPR) it will repeal and replace the existing Cosmetic Products Directive 76/768/EEC (CPD) as of 11 July 2013 Biocidal Regulation (EU) 528/2012 (BPR) it will repeal and replace the existing Biocidal Products Directive 98/8/EC (BPD) as of 1 September 2013 Draft note for guidance CA-May13-Doc.5.1.e Borderline between new Cosmetic Regulation and new Biocidal Regulation

24. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 24 "any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours“ Definition of a cosmetic product under the CPR

25. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 25 "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." Definition of a biocidal product under the BPR

26. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 26 CPR and the CPD apply to all products complying with the definition of a "cosmetic product", based on the area of application and the purposes of their use. The purpose of the product must be "exclusively or mainly" to clean, perfume, change the appearance, protect, keep in good condition or correct body odours. The fact that a cosmetic product may have a "main" cosmetic function allows for secondary functions, which may not be cosmetic. As a result, a product can be covered by the cosmetics legislation even if secondary, non-cosmetic claims are made, provided that it is clear, from the presentation of the product, that such claims are secondary. What products are covered by the cosmetics legislation?

27. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 27 A product complies with the definition of a biocidal product in BPD and BPR only if the product as such is intended to control harmful organisms. This means that, while preservatives in themselves are biocidal products, the mere fact that a cosmetic product contains a preservative does not in itself make the cosmetic a biocide. Under the CPR, preservatives may only be used in cosmetic products if they have been included in the positive list in Annex V of the Regulation following an independent safety assessment by the Scientific Committee for Consumers Safety What products are covered by the biocides legislation?

28. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 28 Products supplied with a main or exclusive cosmetic purpose are cosmetic products, and thus fall within the scope of the cosmetics legislation. If these products are not intended to serve a biocidal purpose, they will not be defined as biocides or covered by the scope of the biocides legislation. Most classic cosmetic products fall within this category, including those which contain preservatives for the sole purpose of preserving the cosmetic product itself. Cosmetic products regulated only through the cosmetics legislation EXECUTIVE SUMMARY

29. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 29 Products supplied with one single primary purpose, which is biocidal, are not covered by the definition of a cosmetic product or by the cosmetics legislation. They fall within the scope of the biocides legislation. Examples include many products making a public health claim relating to biocidal activity, and can include antibacterial hand gels, and antibacterial soaps with such claims. Biocidal products regulated only through the biocides legislation EXECUTIVE SUMMARY

30. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 30 To an increasing extent, classic cosmetic products are being supplied with a claim to serve a biocidal purpose. They therefore fall within the definition of a biocidal product. If the biocidal purpose is only secondary to a cosmetic purpose, or inherent to a primary cosmetic purpose, the product will, however, be entirely excluded from the scope of the biocides legislation and covered only by the cosmetics legislation. Examples: antibacterial soaps without public health claims, and antibacterial deodorants 'Cosmetic and biocidal' products regulated only through the cosmetics legislation EXECUTIVE SUMMARY

31. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 31 There are products serving a primary cosmetic purpose, which serve an equally important biocidal purpose. These will be regulated by the cosmetics legislation with regard to their cosmetic purpose and by the biocides legislation with regard to their biocidal purpose. Examples: insect- or jellyfish repellent sunscreens 'Cosmetic and biocidal' products regulated through both the cosmetics legislation and the biocides legislation EXECUTIVE SUMMARY

32. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 32 The list has been established solely on the basis of product claim. It is important to assess all the characteristics of the product, including not only the claims, but also its presentation, composition and mode of action, on a case by case basis before making a final decision. – Mouthwashes and toothpastes – Shaving gels – Deodorants – Hand and body cleaning wash-off products: soaps, foams and liquids – Hand and body gels, hand and body wipes and other leave-on products – Face washes – Sun block with insect repellent Specific cases of Cosmetic-Biocide legislation borderline

33. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 33 Labelled Primary and/or Secondary Claim Helps prevent dry and tight skin (Cosmetic - function) Helps prevent skin redness associated with shaving’ (Cosmetic - function) Reduces shaving rash/ skin burn due to shaving (Cosmetic - function) Soothes skin whilst shaving (Cosmetic - function) Reduces skin redness due to shaving (Cosmetic - function) Shave cream/gel that kills 99.9% of facial bacteria (Biocide) Shaving gels

34. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 34 Labelled Primary and/or Secondary Claim Correct body odour; Mask body odour (Cosmetic - function) Protects against sweat; Masks sweat (Cosmetic – function) Reduces the signs of sweating (Cosmetic - function) Minimise the effects of sweating (Cosmetic - function) Eliminate bacteria (Biocidal function)* Antimicrobial (Biocidal function)* Antibacterial (Biocidal function)* Deodorants *- needed assessment of all product characteristic

35. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 35 Conclusion

36. TAIEX, Workshop on BPR and Practices, Ankara 6-7 June 2013 36 Thank you for your attention