ECHA e-News - 10 December 2014



ECHA e-News is a weekly update from the European Chemicals Agency

Biocidal Products Regulation

Stay on the market with your biocidal product after 1 September 2015

From 1 September 2015, a biocidal product consisting of, containing, or generating a relevant substance, cannot be placed on the EU market if the substance supplier or product supplier is not included in the Article 95 list for the product type(s) to which the product belongs. An updated guidance is now available.

News alert | Article 95 act now web page

ECHA next week

36th Management Board meeting
16-17 December 2014

RAC and SEAC agree on restriction proposals and evaluate applications for authorisation, agreeing on 43 draft opinions for individual uses

During the plenary meeting at the end of November to early December 2014, the Committee for Risk Assessment (RAC) adopted opinions on two restriction proposals – chrysotile, and cadmium and its compounds in artist paints. The Committee for Socio-economic analysis (SEAC) agreed on draft opinions on the same proposals. SEAC also adopted their final opinion on restriction proposals on cadmium and its compounds in paints and on 1-methyl-2-pyrrolidone (NMP).

News alert | Details on the opinions (Annex)

New consultations on SEAC's draft opinions on restriction proposals for cadmium and its compunds in artists' paints and chrysotile

ECHA has launched a public consultation on the draft opinions of the Committee for Socio-economic Analysis (SEAC) on the restriction proposals for cadmium and its compounds in artists' paints and for chrysotile. The deadline for comments is 8 February 2015. SEAC will consider these comments in its final opinions. In spring 2015 ECHA will submit the opinions of RAC and SEAC to the European Commission.

Current restrictions under consideration

The Biocidal Products Committee adopts eight opinions

The fields of application include active substances for use in biocidal products used as insecticides, wood preservatives, fungicides and disinfectants. In addition, the BPC confirmed the status of piperonyl butoxide (PBO) as an active substance.

News alert

What to do if you don't find your ongoing application or existing product authorisation after its migration from R4BP2 to R4BP 3?

The final migration from R4BP2 to R4BP 3 has now taken place and all ongoing applications for national authorisation of Biocidal products (including mutual recognitions) and all existing national authorisations of Biocidal products that were recorded in R4BP2 have now been moved to R4BP 3. However, for some of the ongoing applications (cases) and existing national authorisations for Biocidal products (assets) it was not possible to allocate to the real legal entity ("orphan" case or asset). To claim the ownership of such "orphan" case or asset the industry users need to contact the respective MSCA. The detailed instructions are available at the links below. Among these "orphan" assets, those relating to authorisations of rodenticide biocidal products containing chlorophacinone, bromadiolone or coumatetralyl should be claimed urgently since they have to be renewed by 28 December 2014.

Please note that due to public holiday, the requests for reallocation of "orphan" cases or assets should be sent by MSCAs to ECHA by Friday 19 December 2014 in order to be processed before January 2015.

R4BP 3 - Register for Biocidal Products - "Orphan" cases & assets

New CLH consultations launched on two biocide active substances

ECHA has started a 45-day public commenting period on the harmonised classification and labelling (CLH) proposal for two biocide active substances - 4,4'-methylenedimorpholine and reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 3:2).

The CLH proposals were both submitted by the Austrian competent authority. 4,4'-methylenedimorpholine (EC 227-062-3) is used as an in-can preservative and a preservative for metal-working fluid. The substance has no harmonised classification and the dossier submitter is proposing classification for health hazards. Reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 3:2) are used among other uses, as a disinfectant and algaecide not intended for direct application to humans or animals, as an in-can preservative and as a preservative for liquid-cooling and processing systems. This substance also has no harmonised classification and the dossier submitter is proposing classification for health hazards and environmental hazards. The final date for submitting comments for the two proposals is 23 January 2015.

Current CLH intentions

The Public Activities Coordination Tool (PACT) updated

The tool for advance notice on substances being considered for risk management (PACT) has been updated with 13 new intentions for RMOA development.

Germany has submitted 7 new RMOA intentions: UV-P (EC 219-470-5), UV-329 (EC 221-573-5), UV-327 (EC 223-383-8), UV-326 (EC 223-445-4), UV-350 (EC 253-037-1), UV-234 (EC 274-570-6) and UV-928 (EC 422-600-5).

France has submitted RMOA intentions for 5 substances: tributyl citrate (EC 201-071-2), tributyl O-acetylcitrate (EC 201-067-0), terephthalic acid (EC 202-830-0), methyl salicylate (EC 204-317-7) and 2,6-di-tert-butyl-p-cresol (BHT; EC 204-881-4).

Sweden has submitted an RMOA intention on 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters (EC 271-094-0).

PACT-RMOA substances

Registry of Intentions updated


One submission withdrawal and one new intention have been added to the Registry of Intentions. The submission withdrawal is: methanol (following the non-conformity of the dossier). The new intention is: methanol (EC number 200-659-6).

Current Restriction intentions | Withdrawn Restriction intentions and submissions

ECHA's Executive Director in exchange of views with the ENVI Committee of the European Parliament

ECHA's Executive Director Geert Dancet appeared before the European Parliament's Committee on the Environment, Public Health and Food Safety on Thursday 4 December in an annual exchange of views. This was an important occasion for ECHA and the first discussion with the Committee since the Parliament elections last May.

News item | Watch the recording of the Committee meeting

QSAR Toolbox 3.3 now available

The QSAR Toolbox helps companies and authorities to use Quantitative Structure-Activity Relationship ((Q)SAR) methodologies to group chemicals into categories and to fill data gaps by read-across or trend analysis to assess the (eco)toxicity hazards of chemicals to be registered under REACH. This helps to reduce costs and the use of vertebrate animals.

News item | QSAR Toolbox project website

Summary of news readership survey results published

Following the closure of our News Readership Survey 2014, an overview of the results is now available on ECHA's website.

Summary of results for News Readership Survey 2014

Frequently asked questions on treated articles available

A revised BPR guidance on treated articles has been published on CIRCABC. The document is an attempt to provide guidance in the interest of consistency. It has been drafted by the Commission services responsible for biocidal products with the aim of finding an agreement with all or a majority of the Member State competent authorities for biocidal products.

Treated articles guidance on CIRCABC (document CA-Sept13-Doc.5.1.e)

Materials from the Workshop on Substance Identification and Substance Sameness available

The aim of the workshop, which took place in ECHA on 6-7 October 2014, was to discuss specific challenging areas of substance identification under REACH and CLP, in particular substance sameness, in order to develop solutions and criteria to assist both industry and regulators adopt a consistent approach.

Workshop materials

Materials from the Workshop on Mode of Action and Human Relevance Framework available

The materials from the workshop "Mode of Action and Human Relevance Framework in the context of Classification and Labelling (CLH) and regulatory assessment of biocides and pesticides" which took place on 4 November 2014 at ECHA are now available on ECHA's website. The workshop was organised by ECHA in collaboration with EFSA.

Workshop materials

The formulators web pages translated

The newly released pages have now been translated in the official EU languages.

Formulators pages


Conference on "Lessons learned on Applications for Authorisation"

10-11 February 2015, Helsinki

The purpose of the conference is to get feedback on the functioning of the application for authorisation process from past, present and future applicants, Member State competent authorities, the Commission and stakeholders as well as ECHA and its scientific committees RAC and SEAC.

Representatives of stakeholder organisations may register their interest on the event page by 6 January 2015.

Event page | Program outline

Ongoing consultations

Start: 18 November 2014
Deadline: 2 January 2015

7 testing proposals

Identification of substances of very high concern

No ongoing consultations

Draft recommendation of substances for the Authorisation List

No ongoing consultations

Harmonised classification and labelling

Start: 28 October 2014
12 December 2014

2 CLH proposals

Start: 13 November 2014
2 January 2015

1 CLH proposal

Start: 9 December 2014
23 January 2014

2 CLH proposals


Start: 18 June 2014
Deadline: 18 December 2014
2 restriction proposals

Start: 10 December 2014
Deadline: 8 February 2015
2 consultations on SEAC draft opinion (new)

Start: 17 September 2014
Deadline: 17 March 2015
1 restriction proposal

Applications for authorisation

Start: 12 November 2014
Deadline: 7 January 2015
17 consultations

Biocides consultation

No ongoing consultations

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