biocidal product family workshop - summary

Chemistry making a world of difference European Chemical Industry Council – Cefic aisbl Avenue E. van Nieuwenhuyse 4 B - 1160 Brussels Belgium Tel: +32 2 676 72 11 Fax: +32 2 676 73 01 [email protected] www.cefic.org

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 2013. 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 10th 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 528/20121

2. 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-C7-0141/2013-2013/°15°(COD))


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 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:109:0004:0013:EN:PDF


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.).


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? Compositions 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.


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 pre-

readings.

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


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


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.


Annex I

List of Participants (Break-out groups)

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

Biocidal Product Family Workshop

Thon Hotel, 10th March 2014

Rue de la Loi 75, 1040 Brussels (Belgium)1040 Brussel


4 CHROBAK Robert Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Poland)

5 COELHO Isabel A.I.S.D.P.C.L. (Portugal)

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)


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)


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) similar uses,

(ii) 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) 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

(b) 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.


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 families4:

- 1st level would describe the composition and permitted variation of the authorised biocidal

family;

- 2nd

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;

- 3rd

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 sub-

groups of products


Annex


Scope of the original authorisation

Individual product compositions

Composition

AS 1 15

AS 2 15

Non-AS 1 50

Non-AS 2 5

Non-AS 2 5

Pigment blue 10

Pigment red 0

Pigment yellow 0

Authorisation Nr: 1-1-a

Composition

AS 1 15

AS 2 15

Non-AS 1 50

Non-AS 2 5

Non-AS 2 5

Pigment blue 0

Pigment red 10

Pigment yellow 0


Composition

AS 1 15

AS 2 15

Non-AS 1 50

Non-AS 2 5

Non-AS 2 5

Pigment blue 0

Pigment red 0

Pigment yellow 10


Composition

AS 1 10

AS 2 15

Non-AS 1 50

Non-AS 2 10

Non-AS 2 5

Pigment blue 10

Pigment red 0

Pigment yellow 0

Authorisation Nr: 1-2-b

Composition

AS 1 15

AS 2 15

Non-AS 1 45

Non-AS 2 10

Non-AS 2 5

Pigment blue 10

Pigment red 0

Pigment yellow 0


Composition

AS 1 15

AS 2 5

Non-AS 1 50

Non-AS 2 10

Non-AS 2 10

Pigment blue 10

Pigment red 0

Pigment yellow 0


Composition

AS 1 15

AS 2 5

Non-AS 1 50

Non-AS 2 10

Non-AS 2 10

Pigment blue 0

Pigment red 10

Pigment yellow 0


Composition

AS 1 15

AS 2 5

Non-AS 1 50

Non-AS 2 10

Non-AS 2 10

Pigment blue 0

Pigment red 0

Pigment yellow 10


Meta SPCs

Composition

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

Composition

AS 1 10 - 15

AS 2 5

Non-AS 1 45 - 50

Non-AS 2 5 - 10

Non-AS 2 5 - 15

Pigment blue 0 - 10

Pigment red 0 - 10


User

General public

Instruction for use

Keep children away


Composition

AS 1 10 - 15

AS 2 15

Non-AS 1 45 - 50

Non-AS 2 5 - 10

Non-AS 2 5 - 10

Pigment blue 0 - 10

Pigment red 0 - 10


User

Professional use

Instruction for use

Wear PPE

Keep children away


Composition

AS 1 10 - 15

AS 2 5 - 15

Non-AS 1 40 - 50

Non-AS 2 5 - 10

Non-AS 2 5 - 15

Pigment blue 0 - 10

Pigment red 0 - 10


Authorisation Nr: 1

Family composition and permitted variations


Actions to be taken before additional products can be placed on the market

Composition

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.

Composition

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

Authorisation Nr: 1-2-c

Product belong to already authorised BPF.

Can be placed on market 30 days after notification.

Same authorisation number, different suffix.

Composition

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

Authorisation Nr: 1-2-d

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.

biocidal product family workshop - summary

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