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

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

/ 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, masterbatchesseems 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.

(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 conferbiocidal (e.g. antimicrobial, insecticidal) properties to bulk products are of relevance in the context of the BPR.

(10)Masterbatches containing active substance 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 masterbatchused falls into the scope of the BPR and, if so, shallbe 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)masterbatchesmanufacturers need not only clarity but also flexibility to meet downstream users demands;

(b)consideringmanymasterbatchesas biocidal products could easily lead toa multiplication of authorisations for products with very similar properties;

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

3. Proposed way forward

(13)The principle must be that at least once in the supply chain in which a biocidal substance is being used, a biocidal product has to be defined.

(14)The person responsible for placing a good on the EU market is responsible for checking compliance with the rules applicable to such a good.

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

(16)It shall be noted that the same product can be regarded as a biocidal product or as a simple mixture depending on the purpose for which it is supplied. It is in particular regarded as a mixturewhen it is supplied for usein the manufacturing process of a biocidal product.

(17)Masterbatches do not have a specific position in BPR. Therefore the 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" and "Frequently asked questions on treated articles"[1].

(18)In particular, the following points should be taken into account by business operators when considering whether amasterbatch falls into the scope of BPR:

(a)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,

(b)A biocidal active substance may be present in a good or mixture at a (high) concentration at which it could exhibit biocidal activity, but this presence may be due to the manufacturing process and not intended to be beneficial for the good or mixture,

(c)Active substances, mixtures, concentrates and other premixes used for the manufacture of a biocidal product shall not be considered as a biocidal product[2],

(d)A masterbatchused to confer a biocidal property to mixtures or articles, which are not biocidal products themselves,a mixture or an article is a biocidal product,

(e)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 or conferring a biocidal property,

(f)Article 3(a) of BPR refers to the form in which a biocidal productis placed on the market,

(g)A decision on whether a masterbatchis a biocidal product will therefore depend on whether it is going to be used to confer a biocidal property to the mixtures or articles in which it is going to be incorporated, or which is are going to be treated with, and which are not biocidal products themselves. If that is the case, the masterbatch shall be regarded as a biocidal product, notwithstanding the masterbatch may confer other non-biocidal functions to the mixture or article (for example color, anti-static).

(h)Intermediate masterbatches, i.e. masterbatches supplied for further processing with a view to prepare the final masterbatch, i.e. the one to be used for treatment or incorporation of the mixture or article, shall not be regarded as biocidal products, as they are not used to confer a biocidal property but as a carrier of an active substance for further processing.

(i)Based on the same reasoning applied for intermediate masterbatches, active substances or mixtures (containing active substances) used to prepare intermediate masterbatches shall not be regarded as biocidal products, as they are not used to confer a biocidal property to the intermediate masterbatches.

(j)Consequently, suchintermediate masterbatches would not have been treated with or would not incorporate a biocidal product containing this specific substance, and shall therefore not be regarded as treated articles.[3]

(19)By considering the above elements, economic operatorsshould be able to determine whether the masterbatchesthey may use fall into the scope of BPR and, if so, shall be considered as biocidal products or not[4].

(20)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.

(21)An illustration of the proposed approach is presented in the Annexto this document.

4. Actionrequested

(22)The Commission invites the CA meeting to discuss and to agree on this proposal.

1

[1]See CA-Nov14-Doc.7.4 and CA-Sept13-Doc.5.1.e (revision December 2014).

[2] There may be exemption to that situation. For instance, an in-can preservative mixture, used during the manufacture of wood preservative product for its in-can protection, is a PT6 biocidal product.

[3]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.

[4]A masterbatch imported into the EU that will be used in the EU to confer a biocidal property or function to a mixture or an article shall be regarded as a biocidal product, even thought it might confer non-biocidal functions as well.