ECHA e-News - 17 December 2014



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

Candidate List

Six new substances of very high concern (SVHCs) added to the Candidate List and one entry updated

Today, ECHA has added six new SVHCs to the Candidate List, based on the agreement of the Member State Committee and updated an existing entry to address an additional reason for inclusion.

Press release | Candidate List for authorisation

ECHA next week

Availability of ECHA's IT tools and Helpdesk support througout year-end

ECHA will be closed from 24 December until 1 January 2015

ECHA is closed for Epiphany 6 January 2015

The Member State Committee unanimously agreed to identify the phthalate DEHP as an SVHC because of its endocrine disrupting properties in the environment

However, the Committee did not reach unanimous agreement on the human health related parts of Denmark's proposals for the four phthalates. For the first time, an MSC opinion with majority and minority views on the SVHC proposals will now be sent to the European Commission for final decision.

News alert | Member State Committee

The Committee for Risk Assessment adopts 23 opinions for harmonised classification and labelling

During its plenary meeting at the end of November to early December 2014, the Committee for Risk Assessment (RAC) discussed and adopted opinions for harmonised classification and labelling of ten inorganic copper compounds. RAC agreed with France to classify all of them among others as very toxic to aquatic life with long lasting environmental effects.

Beside the pesticide and biocidal active substances and the industrial chemicals discussed, RAC also reviewed the information for setting higher specific concentration limits for the reproductive toxicity hazard class of the substance tetrapropylphenol at the request of ECHA's Executive Director.

News alert | Annex

Public consultation launched on the proposed restriction of Perfluorooctanoic acid (PFOA), its salts and PFOA-related substances

Germany and Norway have submitted a report proposing a restriction on the manufacturing, use and placing on the market of perfluorooctanoic acid (PFOA), its salts, as well as substances that may degrade to PFOA (PFOA-related substances). These substances are used in a wide range of industrial applications and consumer goods, e.g. in fluoropolymer and fluoroelastomer production, photographic industry, semiconductor industry, fire-fighting foams, wetting agents, cleaners, textiles and leather, paper and cardboard (including in food packaging) and paints and lacquers (including exterior and interior architectural paints).

This consultation is open from 17 December 2014 to 17 June 2015. ECHA's Scientific Committees welcome early comments by 1 March 2015 to assist them in the first discussion of the proposal in March 2015. Four specific questions have been posed.

Restrictions under consideration

ECHA's IT-tools and Helpdesk support: limited services throughout year-end

Throughout the end of the year, the availability of REACH-IT, R4BP 3 and ECHA contact forms will be limited. ECHA's premises and switchboard will also be closed between 24 December 2014 and 1 January 2015.

News item

First ECHA guidance on the PIC Regulation

The re-cast EU Regulation that governs the export and import of certain hazardous chemicals is in force since 1 March 2014. This guidance document assists dutyholders in applying the specific provisions for the export and import of certain hazardous chemicals under the Regulation.

News alert | PIC Guidance | PIC web pages

Registry of Intentions updated


Sweden has sent an SVHC intention for 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters (EC 271-094-0). The dossier is expected on 2 February 2015.


The Netherlands sent three CLH intentions: 3-decen-2-one (EC 234-059-0), Flupyradifurone (ISO); 4-{[(6-chloropyridin-3-yl)methyl](2,2-difluoroethyl)amino}furan-2(5H)-one (CAS 951659-40-8) and (R)-p-mentha-1,8-diene (EC 227-813-5). The dossiers are expected to be submitted in 2015. Norway sent a CLH intention for 4-tert-butylphenol (EC 202-679-0) and it is expected to be submitted by the end of 2014.

Two CLH intentions were submitted. 4-Chloro-3-methylphenol (EC 200-431-6) was submitted by France and hexaflumuron (EC 401-400-1) by Portugal.

Current SVHC intentions | Current CLH intentions | Submitted CLH proposals

ECHA's Board of Appeal publishes its first substantive decision on data sharing

In case A-017-2013 the Appellant had requested the annulment of an ECHA decision granting a company permission to refer to certain data resulting from testing on vertebrate animals. The Board of Appeal Decision considers whether the Agency had exceeded its competence in considering the details of the cost sharing agreement itself rather than whether the parties to the dispute had made every effort to ensure that the costs of sharing information are determined in a fair, transparent and non-discriminatory way. The Board of Appeal also examines how the 'every effort' requirement had been assessed in this particular case and whether costs only applied to certain registrants can be considered to be discriminatory. In addition, the Decision examines certain procedural issues related to the examination of data sharing disputes by ECHA. The Board of Appeal found, amongst other things, that ECHA had not exceeded its competence and that its approach to the assessment of whether every effort had been made was legally sound. The appeal was therefore dismissed.

Decisions of BoA

Two substance evaluation cases concluded without draft decisions

Two substance evaluation cases from 2013 have been published. In both cases, the evaluating Member State decided not to ask for any further information on the substances and hence no draft decision was prepared. The conclusion documents and the evaluation reports are published on ECHA's website. The conclusion document provides the view of the evaluating Member State on the need for regulatory risk management measures. The substances are the following: trizinc bis(orthophosphate) (EC: 231-944-3), evaluated by Romania; and reaction products of 4-methyl-2-pentanol and diphosphorus pentasulfide, propoxylated, esterified with diphosphorous pentaoxide, and salted by amines, C12-14- tert—alkyl (previously registered as: reaction products of bis(4-methylpentan-2-yl)dithiophosphoric acid with phosphorus oxide, propylene oxide and amines, C12-14-alkyl (branched)) (EC: 931-384-6), evaluated by Slovenia.

CoRAP list of substances

December issue of the ECHA Newsletter published

The December issue of the ECHA Newsletter has been published. In this issue, we tell about how the use of read-across and categories can improve the safety of nanomaterials and explain what benefits the new Public Activities Coordination Tool brings. You can also read our top tips for the CLP 2015 deadline, learn about the new features of the R4BP 3.2 find out how we plan to improve our news products based on the feedback received in the yearly news readership survey. The Newsletter is also always available in PDF format on the Newsletter web page.

Read the Newsletter online | PDF version

Concise guidance for the use of new in vivo genotoxicity test guidelines

ECHA has included two new test guidelines: one on Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays (OECD TG 488) and one on In Vivo Mammalian Alkaline Comet Assay (OECD TG 489) on the webpage on test guidlines. OECD recently approved these test guidelines that are important within the genotoxicity testing strategy under REACH.

The weboage provides advice to registrants on the scope and use of in vivo genotoxicity tests with regard of different information requirements under REACH. To access the documents, please go to the section "Human health" after accepting the disclaimer.

OECD and EU test guidelines

ECHA's webpage on test guidelines includes information on physical-chemical properties, human health, environmental fate and ecotoxicity. The guidelines have been approved by the EU and OECD.

Under the web section "Testing methods and alternatives", companies can find information on test guidelines, non-test methods, grouping of substances and read-across.

Testing methods and alternatives


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.

Companies that have applied or are planning to apply for authorisation may indicate their interest to take part in this event page by 6 January 2015.

Event page | Program outline

Ongoing consultations

Start: 18 November 2014
Deadline: 2 January 2015

7 testing proposals

Start: 12 December 2014
Deadline: 26 January 2015

16 testing proposals (new)

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: 13 November 2014
Deadline: 2 January 2015

1 CLH proposal

Start: 9 December 2014
Deadline: 23 January 2015

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

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

Start: 17 December 2014
Deadline: 17 June 2015
1 restriction proposal (new)

Applications for authorisation

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

Biocides consultation

No ongoing consultations

European Chemicals Agency
P.O.Box 400 FI-00121 Helsinki, Finland


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