Biocidal Product Family Workshop

Transcription

1 Biocidal Product Family Workshop 10 March 2014 Thon Hotel, Brussels Closing Notes (Summary of the presentations, group reports, conclusions and recommendations) 1. Introduction The Biocidal Products Regulation (BPR - Regulation 528/2012(EC)) entered into operation on 1 September It introduced new elements into the system of evaluating and authorising biocidal products in the EU. One of these new elements is the concept of a Family of Biocidal Products (replacing the former frame formulation concept). On the 10 th of March 2014, A.I.S.E. and Cefic organised a workshop with the aim to initiate discussions between Commission, Member States and Industry for establishing a common understanding on the Biocidal Product Family (BPF) concept. Discussions during this one day event focused on identifying policy and procedural questions as well as technical issues in order to correctly and most effectively apply the Biocidal Product Family concept in practice. As a basis for discussion, participants were encouraged to refer to the following existing documents: Technical Notes for Guidance Frame Formulations (CA-Feb11-DOC.6.1A) Amended Biocidal Products Regulation (EU) No 528/ Presentations Opening remarks: The participants of the workshop were welcomed by Gosia Oledzka (Technical and Scientific Affairs Manager, A.I.S.E.). In name of the two organising associations, she thanked the Commission and Member State representatives for participating in this kick-off meeting and hoped for constructive discussions during the different sessions of the workshop. She underlined that the new Biocidal Product Regulation has created new opportunities for biocidal product formulators. However, before Industry and Authorities can benefit from these new concepts, Biocidal Product Family being one of them, further basic questions need to be clarified. 1 European Parliament legislative resolution of 25 February 2014 on the proposal for a regulation of the European Parliament and of the Council amending Regulation EU) No 528/2012 concerning the making available on the market and use if biocidal products with regard to certain conditions for access to the market (COM(2013)0288-C7-0141/ / 15 (COD))

2 1. Introduction session Commission presentation: Meaning and understanding of the updated BPR provisions regarding the Biocidal Product Family concept Pierre Choraine, for the European Commission, presented the amended definition and provisions of the Biocidal Product Family (BPF). He underlined that the constraints of the same classification have been removed. The Commission further explained that, from the legislator point of view, the notification concept is one of the most important elements of the Biocidal Product Family provisions since the authorisation holder can place products falling into the BPF on the market through a quick process of notification (notification at least 30 days before placing it on the market). Therefore, it is advisable that applicants and Authorities clarify upfront what can be notified. The COM explained that when a BPF will be authorised, information could be structured in 3 levels: 1st level would describe the composition and permitted variation of the authorised biocidal family; 2nd level would describe groups of products of the family having similar compositions, the same uses and the same levels of risk and efficacy; 3rd level would provide the composition of the different products of the family; The COM proposed to group biocidal products belonging to a family using composition, intended uses, user type, RMM etc. The main criteria would be that all products in each group should have the same SPC2. In this context, the concept of meta-spc was introduced. It has been explained that each meta-spc will provide information about each individual product in terms of name, composition, authorisation number and suffix. Additionally, it was stated that any changes in the composition of the products going beyond the defined family, will require an application for a change to the granted authorisation via Changes Regulation3. The COM stressed that the proposal is a starting point and will be further discussed at the upcoming Competent Authorities meetings. 2 See Biocidal Product Family (CA-March14-Doc.5.12) in Annex II of the document 3

3 Industry presentation: Aim, expectations and boundaries of the Biocidal Product Family (BPF) concept Nathalie Hanon for Industry reminded the participants that until now a lot more experience has been gained around the active substances approval comparing to the authorisation of biocidal products. Industry welcomed the amendments of the BPR text which focus on the risk approach and provide more flexibility. However, it was underlined that both Industry and Authorities need to better understand how to implement the BPF concept in practice. Industry stressed that the BPF will offer the possibility to reduce the workload both for applicants and Member States. It was recognised that there is a very high interest in this concept but the level of understanding has some space for improvement. Moreover, the COM and MS should reflect on how the best implement this new concept. Industry expressed hope that the current workshop is a good starting point towards the development of a guidance document in the future. Introduction to the break-out session topics Participants were informed that, for the purpose of the workshop, three examples of biocidal product families were prepared: PT2/PT4, PT3 and PT8. These examples were to be discussed in four break-out sessions: Understanding similar levels of risk, Understanding similar uses, Understanding similar levels of efficacy, Post-authorisation and procedural considerations related to BPF. It was stressed that discussions during break-out sessions should not focus on issues which are also related to single BP authorisation. 2. Break-out discussion sessions & plenary discussion Session 1: Understanding similar levels of risk This group focused on understanding the concept of similar risk for Biocidal Product Family. Main questions identified by the group are: Q1: How to align the two concepts: Maximum risk (as in the new Art 19(6)) and Similar level of risk (as in the new Art 3(1) s)? The group recommended that one should focus on the Maximum Risk, which should be identified for each meta-spc for each aspect of the Human Health (HH) and Environment (ENV) Risk Assessments (RA) (taking into consideration the composition of the products, the uses, user categories etc.). Q2: Can the worst case considerations be based on different Family members? It was agreed by the group that a single worst case product for the entire BPF or for each Meta SPC could not always be identified. It was recognised that the worst case for each element of the HH and ENV RA may be addressed by different products (depending on composition, use, user type etc.).

4 Q3: How can Similar composition with specified variations be understood with regard to the risk approach? It was agreed that different compositions can be addressed with regard to the RA approach. However, certain boundaries may need to be identified e.g. Formulation type (liquid/bait, or concentrate vs. Ready to Use). Overall, it was concluded that a case by case assessment will have to be applied. Q4: Can we have different RMMs (Risk Management Measures) in the same Family? It was agreed that one can have different RMMs within the same BPF but each Meta SPC should have its own set of RMMs. RMMs will always be established on the basis of the worst case of that Meta SPC. At the time of notification, the applicant will have to accept the RMMs set out in the Meta SPC, even if his specific product would not trigger such RMMs. If not, then the Changes Regulation will apply to split the Meta SPC. The group identified a number of further recommendations: Work on the Risk Envelope approach taking the document from Ireland into account. Build on the Commission proposal with practical examples from multiple PTs as this can be PT specific Policy discussion on active substance percentage down to 0% at CA meeting Session 2: Understanding similar uses This group focused on defining and applying the concept of similar use to biocidal product families. Q1: Can different user types be combined in one BPF (Professional and non-professional)? The group agreed that this would be possible, since different user types could be covered by separate meta-spc s. Q2: Can a BPF combine different PTs? Can I have a PT 2, and PT 4 and a PT2/4)? The group agreed that in principle it will be possible, but in practice it would depend on the product characteristics. It was recommended to group meta-spc products based on their PT in order to limit the complexity. Q3: Is it possible to group different application methods? s will be linked to application methods which are not interchangeable can they be combined? The group agreed that in principle different application methods could be included into one BPF. However, it may be easier for some PTs (i.e. PT3 and PT8 products) over other (e.g. PT2/PT4). It was recognised that for complex cases this approach would not be recommended.

5 Q4: Can different physical states be combined (e.g. powder, liquid, grain bait, gel, waxblock) This decision should be linked directly to composition, as one ingredient can make the difference. It was underlined that a flexible approach would be appreciated. Q5: Can the claims differ (e.g. fungicide and/or Insecticide)? The group concluded that this would depend on the active substances. In principle, different formulations should be allowed to have different claims. The group has identified a number of further recommendations: Meta-SPC approach provides opportunities but some flexibility will be needed It is important to hold a pre-meeting with Evaluating MS to clarify different aspects and limitations of the proposed families Applicants should refrain from creating too complex BPFs. Session 3: Understanding similar levels of efficacy This group assumed in its discussions that it is possible to group different PTs within one family. The group concluded that different claims are possible within one family. Moreover, each meta-spc will have to be supported by dedicated testing strategy for efficacy. The group recommended a stepwise approach to answer three questions identified in the prereadings. Below stepwise approach was recommended for establishing BPF efficacy: I. Search for the extreme based on the active(s) substance(s): - implement complete tests for minimum requirements according to guidance II. Provide expert judgement to evaluate potential impact of co-formulants - in-house data - scientific knowledge III. Provide additional tests on limited strains as identified in step 1 and 2 for: - confirming impact of co-formulants - supporting additional claims Further recommendations This stepwise approach applies only if a clear guidance for minimum efficacy requirements exists for all PTs

6 Session 4: Post-authorisation and procedural considerations related to BPF. This group focused on post-authorisation management of granted authorisations, such as adding new products to the BPF, making changes to existing authorisation etc. Q1: When is Notification not required? The group confirmed the text of the BPR, namely that no notification is required in cases where a particular product was explicitly listed during the establishment of the BPF or the variation in composition concerns only known pigments, perfumes and dyes. Q2: When is Notification required? The group agreed that notification is required where a particular product is not explicitly defined in the existing authorisation or where the variation in composition concerns substances other than pigments, perfumes and dyes while remaining within the defined ranges. Q3: Is a family defined only by its existing members? The group agreed that it is not necessary for all products within the BPF to be placed on the market at the time of approval. Q4: Does the family range have to fit to the existing members, or can a range be larger? The group agreed that the range can be larger. Q5: How to extend the range of the family Major vs. Minor Change? The group agreed that the application type of such extensions of the family need to be decided on a case-by-case basis, depending on the extent of the scientific/technical assessment to be performed. Q6: Will it be possible to add an additional PT to the family - for example PT2 family becomes PT2/PT4? The group agreed that this could be possible based on RA update (application for a change). Q7: Is it possible to apply for a same product authorisation regarding only one family member? The group concluded that the current legislative text does not allow this, however further reflection is needed on this issue. The group has identified a number of additional - questions that need further consideration: How to construct a Family SPC Will each product in a BPF require an SPC Is the current SPC template for a BPF adequate to fit the new proposal

7 3. Overall conclusions and recommendations The closing messages of the workshop were presented by David Ashworth. It was stressed that the objective of the workshop was to initiate discussion concerning practical applicability of Biocidal Products Family. Industry welcomed the proposal for meta-spc presented by the Commission. However, based on the discussions during the day it is clear that further reflection on this issue is needed. The Workshop was seen as a good initiative and Industry representatives were encouraged to continue the work on this issue and possibly consider developing an industry guidance document in the future.

8 Annex I List of Participants (Break-out groups) Biocidal Product Family Workshop Thon Hotel, 10 th March 2014 Rue de la Loi 75, 1040 Brussels (Belgium)1040 Brussel BREAK-OUT GROUPS Session 1: Understanding similar levels of risk Last Name First Name Organisation 1 CATALDI Lucilla Istituto Superiore di Sanita (Italy) 2 CHANNI Arjun ReckittBenckiser Healthcare Ltd (United Kingdom) 3 GONZALEZ MARQUEZ Luisa Ministry of Health (Spain) 4 GRAY Adrian Janssen PMP, a division of Janssen Pharmaceutica NV (Belgium) 5 HANON Nathalie Troy Chemical Company EU (Spain) 6 HUSZAL Sylwester Office for registration of medicinal products, Medical devices and biocidal products (Poland) 7 JANTONE Anta Latvian Environment, Geology and Meteorology Center (Latvia) 8 JOHANNSSON Grimur EFTA 9 KUCERA Tomas Ministry of Health (Czech Republic) 10 KULD Piret Health Board (Estonia) 11 LAS HERAS Alfonso EC, DG Environment 12 MIHAI Camelia Cefic (Belgium) 13 PATEL Tina Rockline Industries Ltd (United Kingdom) 14 POTTIE Lode Federal Public Service Health (Belgium) 15 ROMANO Laura ASSOCASA (Italy) 16 RUMP Elmar Bayer S.A.S. (France) 17 LEMOINE Sylvie A.I.S.E. 18 VAN CORVEN Danielle Sealedair (The Netherlands) 19 WITTMANN Olga Lanxess GmbH (Germany) 20 WOODHEAD Peter Selden Research Ltd (United Kingdom) Session 2: Understanding similar uses 1 BATTEN Vicki SC Johnson (United Kingdom) 2 BESSLER Cornelius Henkel AG & Co KGaA (Germany) 3 CHORAINE Pierre EC, DG Environment

9 4 CHROBAK Robert 5 COELHO Isabel A.I.S.D.P.C.L. (Portugal) Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Poland) 6 COURTY Benoît Agency for Food, Environmental and Occupational Health (France) 7 GOMEZ GALLEGO Prado Ministry of Health (Spain) 8 GRUNWALD Ludger Ecolab (Germany) 9 GUTIERREZ Simon Lonza (United Kingdom) 10 HÜHN Michael BK Giulini GmbH (Germany) 11 LODINI Sara Activa S.r.l. (Italy) 12 MAJUS Saulius Public Health Centre (Lithuania) 13 MORONCELLI Sonia Sopura (Belgium) 14 NIJS Eric EC, Federal Public Service DG V (Belgium) 15 PLACHETKA Annette Bundesanstalt für Arbeitsschutz und ArbeitsmedizinBundesstelle für Chemikalien (Germany) 16 RAMOS Cesaltina Direção-Geral da Saúde (Portugal) 17 REPO Kaarina Safety and Chemicals Agency (Finland) 18 TSIGA Gamu Rockline Ltd (United Kingdom) 19 VERHELLE Patrick Coprodes (Belgium) 20 VRHOVAC FILIPOVIC Ivana Ministry of Health - Department of Chemicals & Biocidal Products (Croatia) 21 WILZ Michael Stockmeier Chemie (Germany) Session 3: Understanding similar levels of efficacy 1 AHLFORD Kristina Sumitomo Chemical PL (United Kingdom) 2 ASHWORTH David British Association for Chemical Specialities (BACS) (United Kingdom) 3 BERGMAN BAILEY Lisa Sumitomo Chemical Plc (United Kingdom) 4 CABELLA Renato Istituto Superiore di Sanita (Italy) 5 COLOMER Jaume Thor Especialidades S.A. (Spain) 6 DELFOSSE Thomas Procter & Gamble (Belgium) 7 DEMOMENT Isabelle Hypred SA (France) 8 GUTKNECHT Jürgen Peracetic Acid Registration Group (Belgium) 9 HILL Andrew McBride Plc (United Kingdom) 10 KOCH Cornelia Vink+Co GmbH Handelsgesellschaft (Germany) 11 KRAJNIK Paul Federal Ministry of Agriculture, Forestry, Environment and Water Management (Austria) 12 PAPUKASHVILI Nino Bode Chemie (Germany) 13 PARKER Tina Unilever R & D (United Kingdom) 14 RAZENBERG Johannes NVZ (The Netherlands) 15 VAN DE VELDE Anja Christeyns N.V. (Belgium) 16 VANHEMELEN Ann FOD VVVL, DG Leefmilieu, Dienst biociden (Belgium) 17 WHELAN Michelle Department of Agriculture, Food and the Marine, Backweston Laboratory Complex (Ireland) Session 4: Post-authorisation and procedural considerations related to BPF 1 AZDAD Karima SPF Santé Publique, Sécurité de la Chaîne Alimentaire et Environnement (Belgium) 2 BERTAGNA Pierre-Loic Ministry of Ecology, Chemical Substances and Preparations Unit (France) 3 BLOCK Christian Colgate Palmolive (Germany) 4 BRUYNDONCKX Raf Cefic (Belgium) 5 CHATELIN Ludovic EC, DG Environment 6 DAEHLI Merete Environment Agency, Section for Biocides and Global Chemical Conventions (Norway) 7 FUNK Markus ASHLAND (Germany)

10 8 GRISAI Laura Federchimica (Italy) 9 HANWAY Rosalind Competent Authority for Biocides, Health and Safety Executive (United Kingdom) 10 JABRANE Abdelhamid Groupe de Formulateurs Biocides (France) 11 JORDAN Jessica Bundesanstalt für Arbeitsschutz und Arbeitsmedizin Bundesstelle für Chemikalien (Germany) 12 NORDBERG Anna Chemicals Agency (Sweden) 13 OLEDZKA Gosia A.I.S.E. 14 PERRONE Raffaella Ministero della Salute (Italy) 15 PLATTNER Edmund BMLFUW (Austria) 16 SANDOR Karikas Babolna Bio Ltd (Hungary) 17 SZYMANKIEWICZ Katarzyna ECHA 18 ÜBEL Caroline Thor GmbH (Germany) 19 VAN BERLO Boris FOD Volksgezondheid, Veiligheid van de Voedselketen en Leefmilieu - DG Leefmilieu - Afdeling Productbeleid en Chemische Stoffen (Belgium) 20 VAN GALEN Joost CTGB (The Netherlands) 21 VERWILGHEN Frederic CEPA (Belgium) 22 WALLENHORST Thomas Sanitized AG (Switzerland)

11 Annex II Biocidal Product Families (CA-March14-Doc.5.12) The amended version of the BPR will provide a new definition for biocidal product families, which will be defined as: a group of biocidal products having: (i) (ii) similar uses, the same active substances, (iii) similar composition with specified variations, and (iv) similar levels of risk and efficacy. The text also provides that the assessment of the biocidal product family conducted according to the common principles set out in Annex VI shall consider the maximum risks to human health, animal health and the environment and the minimum level of efficacy over the whole potential range of products within the biocidal product family. Furthermore, the new text establishes that a biocidal product family shall be authorised only if: (a) (b) the application explicitly identifies the maximum risks to human health, animal health and the environment, and the minimum level of efficacy, on which the assessment is based, as well as the permitted variations in composition and uses referred to in point (s) of Article 3(1) together with their respective classification, hazard and precautionary statements and any appropriate risk mitigation measures; and it can be established based on the assessment referred to in the first subparagraph of this paragraph that all the biocidal products within the family comply with the conditions set out in paragraph 1. This new definition and approach, by removing the constraints of the previous definition, should provide for new opportunities. In addition, once the biocidal product family is authorised, the objective remains to facilitate the placing on the market of new products belonging to the biocidal product family but not explicitly identified in the original authorisation.

12 To that effect, a notification mechanism is to be used by authorisation holders to inform competent authorities that they intend to place on the market such new products except when the variation in composition concerns only pigments, perfumes and dyes within the permitted variations, in which case no notification is required. This notification shall indicate the exact composition and trade name of the product, as well as the suffix to the added to the authorisation number. As no other information is requested, it implies that the SPC of the product covered by the notification shall be identical in all parts, but the elements notified, to the one agreed at the time of the authorisation of the biocidal product family. However, as the new definition provides for products having similar uses and similar levels of risks and efficacy, it also implies that products within the same family, in addition to having different composition can be intended for different uses, category of users, etc which would thus lead to different SPCs for these products. It is therefore important at the time of the authorisation of the biocidal family, when the family entails products with different uses, user categories, risk or efficacy levels, to define precisely what is authorised. It is thus proposed that the authorisation, on the basis of the conclusions of the risk and efficacy assessment, and of the acceptable uses, shall provide information in a structured way that would make it easy to understand what is exactly authorised and would ensure that later notifications can be handled within 30 days by Competent Authorities. The proposal would thus be to provide three levels of information in authorisations of biocidal product families 4 : - 1 st level would describe the composition and permitted variation of the authorised biocidal family; - 2 nd level would provide the meta SPC, which would describe groups of products of the family having similar compositions, the same uses and the same levels of risk and efficacy; - 3 rd level would provide the composition of the different products of the family. The Commission services invite participants to the workshop to discuss the proposal. 4 The chart in annex illustrates how the proposal would work for a biocidal product family comprising three subgroups of products

13 Annex

14 Scope of the original authorisation AS AS Non-AS Non-AS Non-AS Pigment blue 0-10 Pigment red 0-10 Pigment yellow 0 10 Authorisation Nr: 1 Family composition and permitted variations AS 1 15 AS 2 15 Non-AS 1 50 Non-AS 2 5 Non-AS 2 5 Pigment blue 0-10 Pigment red 0-10 Pigment yellow 0 10 User Industrial use Instruction for use Wear PPE Authorisation Nr: 1-1 AS AS 2 15 Non-AS Non-AS Non-AS Pigment blue 0-10 Pigment red 0-10 Pigment yellow 0 10 User Professional use Instruction for use Wear PPE Keep children away Authorisation Nr: 1-2 Meta SPCs AS AS 2 5 Non-AS Non-AS Non-AS Pigment blue 0-10 Pigment red 0-10 Pigment yellow 0 10 User General public Instruction for use Keep children away Authorisation Nr: 1-3 AS 1 15 AS 2 15 AS 1 15 Non-AS 1 50 AS 2 15 AS 1 15 Non-AS 2 5 Non-AS 1 50 AS 2 15 Non-AS 2 5 Non-AS 2 5 Non-AS 1 50 Pigment blue 10 Non-AS 2 5 Non-AS 2 5 Pigment red 0 Pigment blue 0 Non-AS 2 5 Pigment yellow 0 Pigment red 10 Pigment blue 0 Pigment yellow Authorisation 0 Nr: 1-1-a Pigment red 0 Pigment yellow Authorisation 10 Nr: 1-1-a Authorisation Nr: 1-1-a AS 1 10 AS 1 AS AS 2 Non-AS Non-AS 2 Non-AS Non-AS 2 Non-AS Pigment blue Non-AS Pigment red Pigment blue 10 0 Pigment yellow Pigment red 0 0 Pigment yellow Authorisation 0 Nr: 1-2-b Pigment yellow 10 Authorisation Nr: 1-2-a Avenue E. van Nieuwenhuyse 4 B Authorisation Brussels Belgium Nr: 1-3-a Individual product compositions AS 1 15 AS 2 5 AS 1 15 Non-AS 1 50 AS 2 5 AS 1 15 Non-AS 2 10 Non-AS 1 50 AS 2 5 Non-AS 2 10 Non-AS 2 10 Non-AS 1 50 Pigment blue 10 Non-AS 2 10 Non-AS 2 10 Pigment red 0 Pigment blue 0 Non-AS 2 10 Pigment yellow 0 Pigment red 10 Pigment blue 0 Pigment yellow Authorisation 0 Nr: 1-3-a Pigment red 0 Authorisation Nr: 1-3-a

15 Actions to be taken before additional products can be placed on the market AS 1 15 AS 2 15 Non-AS 1 50 Non-AS 2 5 Non-AS 2 5 Pigment blue 5 Pigment red 0 Pigment yellow 5 Product belongs to already authorised BPF. Can be placed on market without notification as only variation relates to pigment content, Same authorisation number, same suffix. Authorisation Nr: 1-1-a AS 1 12 AS 2 12 Non-AS 1 48 Non-AS 2 9 Non-AS 2 9 Pigment blue 5 Pigment red 0 Pigment yellow 5 Product belong to already authorised BPF. Can be placed on market 30 days after notification. Same authorisation number, different suffix. Authorisation Nr: 1-2-c AS 1 16 AS 2 8 Non-AS 1 48 Non-AS 2 9 Non-AS 2 9 Pigment blue 5 Pigment red 0 Pigment yellow 5 Product does not belong to already authorised BPF. Can be placed on market after change to authorisation has been approved. Same authorisation number, different suffix. Authorisation Nr: 1-2-d