Subject: Guidance on the Application of Provisions of BPR on Masterbatches

CA-Sept15-Doc.6.2 - Final

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Safety of the Food Chain Pesticides and Biocides

NOTE FOR GUIDANCE

This document is an attempt to provide guidance in the interest of consistency, and has been drafted by the Commission services responsible for biocidal products with the aim of finding an agreement with Member States' Competent Authorities for biocidal products. Please note, however, that Member States are not legally obliged to follow the approach set out in this document, since only the Court of Justice of the European Union can give authoritative interpretations on the contents of Union law.

Subject: Guidance on the application of provisions of BPR on masterbatches

1. Purpose of the document

(1) The purpose of this note is to clarify the position of masterbatches in the context of Regulation (EU) No 528/2012 (the BPR) and to propose a way forward in order to decrease uncertainty.

2. Background

(2) In 2014 the Commission and Member State Competent Authorities have repeatedly been approached with questions concerning the status of so-called "masterbatches" under the BPR, in particular in the light of Article 58 of the BPR concerning treated articles.

(3) In July 2014 the Commission requested information to stakeholders on this issue in order to better understand how and to what extend masterbatches are used in various industrial processes. Input was received from several stakeholders.

(4) In May 2015 the Commission presented a discussion note on masterbatches to the competent authorities for biocides and Member States and stakeholders were requested to send comments by 30 June 2015.

(5) The concept of masterbatch appears not to be clearly delimited and in practice the meaning seems to be linked to the type of supply chain in which it is being used. As a common feature, masterbatches seems to be the carrier mechanism used for the addition of properties to a final product. Masterbatches can be used directly into a manufacturing step and having the objective to facilitate adding additives accurately and to have them homogenously distributed within such a product.

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111 Office: DM24 2/44 - Tel. direct line +32 229-02 2950178 (6) Although the BPR does not contain a definition of the concept of masterbatch, for the purpose of its implementation, the following common definitions would apply.

(7) A masterbatch is a pre-dispersed (solid or liquid) concentrate of additive(s), such as pigments, anti-static, UV-blockers, flame retardants, antimicrobials (biocides)…, allowing the processor to proportion such additives accurately to a bulk product (for example natural polymer) during the manufacturing process.

Masterbatch addition is considered the industrial standard way for adding additives to the bulk product, and is typically in a form (for example granulates or pellets) making them easy to handle and to mix. Those additives are metered, or let down, into a bulk product using a predefined ratio, during the processing.

(8) Masterbatches are typically commercial products made available on the market in a business to business relationship.

(9) Of all masterbatches, only those used to confer biocidal (e.g. antimicrobial, insecticidal) properties to bulk products1 are of relevance in the context of the BPR.

(10) Masterbatches containing active substance(s) with a view to confer biocidal properties to the final article are abundantly used in polymer production processes.

(11) It is necessary to develop an approach so that each business operator in a specific supply chain would be able to determine whether or not the masterbatch used falls into the scope of the BPR and, if so, shall be considered a biocidal product or a treated article. This will allow business operators to comply with the rules, and Member States enforcement authorities to assess compliance.

(12) It is also acknowledged that:

(a) masterbatches manufacturers need not only clarity but also flexibility to meet downstream users demands;

(b) considering many masterbatches as biocidal products could easily lead to a multiplication of authorisations for products with very similar properties;

(c) the concept of biocidal product family could however be used in that context.

3. Principles

1 Polymer sheets are typical examples of bulk products that, after incorporating the masterbatch, may have been conferred biocidal properties. In such case, the bulk product is a treated article. In subsequent steps, all articles formed by for example moulding, rolling or folding of these polymer sheets shall be regarded as treated articles as they all intentionally incorporate the biocidal product. (13) The person responsible for placing a good on the EU market is responsible for checking compliance with the rules applicable to such a good.

(14) At least once in the supply chain in which a biocidal substance is being used, a biocidal product has to be defined.

(15) For each supply chain in which masterbatches are used, economic operators have to determine the status of these masterbatches.

(16) Established guidance should be applied, in particular the guidance on "concepts of placing and making available on the market in the context of Regulation (EU) No 528/2012"2 and "Frequently asked questions on treated articles"3.

(17) The following points should in addition be taken into account by economic operators to determine whether the masterbatches they place on the market or use fall into the scope of BPR and, if so, shall be considered as biocidal products or not4:

(a) Conferring a biocidal property5 to an article or a mixture is a biocidal function6,

(b) A masterbatch should be regarded as a biocidal product if it is has a biocidal function in the form in which it is supplied to the user,

(c) The user of a biocidal product is the person who is going to use the biocidal product with a view to exerting a biocidal function,

(d) A substance which is known to have biocidal activity may be used for reasons unrelated to this biocidal activity in a certain step of the manufacturing process,

(e) A substance may be present in an article or mixture at a concentration at which it could exhibit biocidal activity, but this presence may be due to the manufacturing process and not intended to confer a biocidal property to the article or mixture,

(f) Active substances, mixtures, concentrates and other premixes exclusively intended or used for the manufacture of a biocidal product, shall not be considered as biocidal products in so far as they are not intended to exert a biocidal function themselves in the form in which they are supplied to the user7,8,

2 See CA-Nov14-Doc.7.4. 3 See CA-Sept13-Doc.5.1.e (revision December 2014). 4 A masterbatch imported into the EU that will be used in the EU to confer a biocidal property to a mixture or an article shall be regarded as a biocidal product, even thought it might confer other non- biocidal properties as well. 5 A biocidal property means a characterising quality or trait resulting from the fact that the mixture or article has been treated with or intentionally incorporates a biocidal product with the intention to prevent the action of harmful organisms. See also See CA-Sept13-Doc.5.1.e (revision December 2014). 6 In accordance with Article 3(1)(a) of Regulation (EU) No 528/2012, destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on any harmful organism is a biocidal function. (g) Based on the same reasoning, intermediate masterbatches9 shall not be regarded as biocidal products, when they are not intended to exert a biocidal function in the form in which they are supplied to the user.

(h) Furthermore, such intermediate masterbatches, in so far as they would not have been treated with or would not incorporate a biocidal product, shall not be regarded as treated articles.10

(i) Whether a masterbatch may confer other non-biocidal properties to the treated mixture or article (for example color, anti-static) is not relevant for the purpose of determining whether this masterbatch falls within the scope of the BPR.

(18) Finally, it shall be noted that for the need for flexibility masterbatches can be addressed through the concept of ‘biocidal product family’, which could allow the grouping of masterbatches with:

(a) Similar uses; (b) The same active substances; (c) Similar composition with specified variations; and (d) Similar levels of risk and efficacy

and have them authorised through a single authorisation as a biocidal product family.

7 See also Commission Implementing Decision (EU) 2015/411 of 11 March 2015 pursuant to Article 3(3) of Regulation (EU) No 528/2012 of the European Parliament and of the Council on cationic polymeric binders with quaternary ammonium compounds incorporated in paints and coatings Text with EEA relevance OJ L 67, 12.3.2015, p. 30–31 8 In-can preservative mixtures, used during the manufacture of wood preservative product for its in-can protection, as they are intended to have a biocidal function, are regarded as PT6 biocidal products. 9 The term ‘intermediate masterbatch’ refers to a masterbatch supplied for further processing with a view to prepare a final masterbatch and the terms ‘final masterbatch’ to the masterbatch used for treatment of or incorporation in the mixture or article. 10 It is important note that this reasoning applies for the situation of a masterbatch that incorporates only a specific product with the objective to confer a biocidal property to a polymer. In theory it is possible that another product, a biocidal product, would be added to this masterbatch to confer a biocidal property. In that specific situation the (intermediate) masterbatch has to be considered a treated article.