Classification and Labelling of Treated Mixtures

CA-March14-Doc.6.3

56th meeting of representatives of Members States Competent Authorities for the implementation of Regulation 528/2012 concerning the making available on the market and use of biocidal products

Classification and labelling of treated mixtures

At the last CA meeting, a discussion took place concerning the application of the specific provisions introduced in several approval regulations of active substances which are skin sensitizers[1], for instance in the approval regulation for IPBC for PT06 [2](Regulation (EU) 1037/2013). In particular, the Commission services proposed to revise the specific condition, to limit the labelling requirement to treated articles which are 'articles', considering that the CLP legislation already establishes rules concerning the labelling of mixtures containing skin sensitizing substances and that the CLP legislation should be considered as sufficient to address the related concerns.

Several comments were sent by Members States and stakeholders after the meeting, as presented in the Appendix 1 to this document.

Having considered these comments, the Commission services maintain its opinion and propose to modify the existing approval regulationsthat included thiscondition[3], and align them with the approval regulation on DCOIT[4].

The Commission services invite the Member States Competent Authorities for the implementation of Regulation (EU) No 528/2012 to endorse this approach.

Appendix 1

Comments from Member States and Stakeholders

Comments from NL

"The discussion for IPBCwas raised as the person who is responsible for the active substance is not the same as the one who is putting the treated article on the market. Therefore an additional condition was included in the approval decision.For products like paints, ink, adhesives, the requirements of labellingthereof are properly regulated through CLP regulation, the NL agrees with the view of the Commission services not to duplicate or complementing it through BPR. However, when a treated article is not within the scope of CLP, additional provisions in the inclusion Directive may still be necessary to instruct labelling for the treated article."

Comments from DE

"We argued that the labelling requirements according to the CLP Regulation do not have the same quality as the requirements of article 58 (3) of the BPR. We explained that for certain product types the additional information in accordance to the BPR could be of great value. Thus, we proposed that mixtures should not be per se excluded from this measure. You indicated to reflect on the document."

Comments from SE

"We have considered the Commission’s proposal and have the following response. We do not support the substitution of “articles” according to the REACH definition for “treated articles” according to BPR in the specific provision that is currently used for active substances that are sensitizers and are used to treat articles.

We understand the desire to avoid double labelling of exactly the same information but the labelling requirements according to Article 58(3) of the BPR go further than CLP requirements. For example, articles that are treated with potent sensitizers at concentrations lower than their concentration limits should also be labelled with a warning for a risk for sensitization. In addition, Article 58(3) requires labelling of other aspects that are not addressed by CLP at all.

We do not consider that the last subparagraph of Article 58(3) can be used to solve the problem since it grants exemption from the whole of paragraph 3 and refers to sector-specific legislation, which CLP is not. We are open to discuss other solutions to avoid double labelling."

Comments from AISE

"A.I.S.E. thanks the European Commission for their assessment of CLP labelling requirements and welcomes the proposal to distinguish treated articles (to be labelled according to BPR requirements) and ‘treated substances/mixtures’. The latter are subject to CLP provisions and if applicable to sector specific labelling provisions[5]. CLP provisions have been designed to ensure safety for all substances and mixtures and inform users of chemicals accordingly, while treated ‘articles’ which are ‘articles’ under REACH and/or CLP are not covered by CLP provisions. Therefore, the labelling provisions stated in Implementing Acts for approval of active substances should only be applicable to preserved articles not subject to other labelling requirements. A.I.S.E. believes that further analysis needs to be done. However, where CLP applies, BPR labelling should not apply in addition.

At the last CA meeting, some Member States voiced concerns with regard to active substances with sensitising properties. We would like to stress that the 2nd ATP to CLP (Regulation (EC) No. 286/2011) has introduced new requirements for the labelling of sensitisers: one level for mixtures that are classified as sensitisers, and a second lower level for warning about the presence of a sensitising substance that could elicit allergic symptoms[6]. For example, for BIT (subject to harmonised classification, with specific concentration limit of 0.05% or 500 ppm for classification), the additional labelling requirement would apply at a level of 0.005% or 50 ppm. This level is internationally considered as protective for sensitised people as it emanates from UN and OECD agreements."

Comments from CEFIC

"The European Commission has decided to include in the approval implementing regulation for all active substances classified as skin sensitising a specific treated article labelling provision.

In the case of IPBC in PT6 (Regulation 1037/2013) the following text has been included:

“Where a treated article has been treated with or intentionally incorporates IPBC, and where necessary due to the possibility of skin contact as well as the release of IPBC under normal conditions of use, the person responsible for placing the treated article on the market shall ensure that the label provides information on the risk of skin sensitisation, as well as the information referred to in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.”

Implementation of this treated article labelling provision when treated articles are chemical mixtures under the scope of the Regulation 1272/2008 (CLP)

We are concerned that such new labelling information may be required in addition to the existing CLP requirements. This would be very confusing and difficult to implement.

The CLP already requires that chemical mixtures containing skin sensitising substances must be:

Classified and labelled as Skin Sens. with hazard phrase H317 “May cause an allergic skin reaction” when they contain substances classified as Skin Sens. 1, 1a or 1b in concentration higher or equal to their concentration limit (which can be either 1% or a lower specific concentration).
Labelled with warning phrase EU H208 “Contains (substance). May cause an allergic reaction.” when substances classified as Skin Sens. 1, 1a or 1b are present at or above 1/10th of their classification limit for sensitisation.

We believe that the CLP requirements are already protective enough, are well known within the industry and will be applied in a defined timeframe to all chemical mixtures (On September 1st, 2015) whether manufactured in the EU or imported.

We believe that adding different labelling requirements to chemical mixtures containing skin sensitising substances would be confusing, counter-productive and probably not applied in a harmonised way in particular in imported products.

Implementation of this treated article labelling provision when treated articles are not chemical mixtures

In the more general case when a treated article is not a chemical preparation, there are no guidelines for determining at which concentration a specific warning is needed for sensitisation effects.

We believe that in this case, a qualitative assessment should be conducted as part of the product authorisation or as part of the active substance approval, taking into account:

-The potential for release of the active substance out of the treated material: determination of the dislodgeable residues level

-The potential for skin exposure to the treated article

-The practical feasibility of labelling the treated article.

Then labelling should be required if the potential for a skin sensitisation reaction is demonstrated in practical conditions of use.

This can be addressed either at product authorisation level or at active substance approval level."

[1]Document "CA-March14-Doc.6.4 - Classification and labelling of treated mixtures.doc"

[2]Commission Implementing Regulation (EU) No 1037/2013 of 24 October 2013 approving IPBC as an existing active substance for use in biocidal products for product-type 6

[3]Commission Implementing Regulation (EU) No 955/2013, Regulation (EU) No 1032/2013, Regulation (EU) No 1037/2013 and Regulation (EU) No 92/2014 define the conditions for approval of propiconazole for use in biocidal products for product-type 9, bromoacetic acid for use in biocidal products for product-type 4, 3-iodo-2-propynyl butylcarbamate (IPBC) for use in biocidal products for product-type 6 and zineb for use in biocidal products for product-type 21

[4]Commission Implementing Regulation (EU) No 437/2014 of 29 April 2014 approving 4,5-Dichloro-2-octyl-2H-isothiazol-3-one as an existing active substance for use in biocidal products for product-type 21

[5]e. g. preservation agents and allergenic fragrances according to Detergent Regulation

[6]this lower level is 1/10th of the generic or substance-specific concentration limit