ECHA e-News - 10 June 2015

ECHA e-News template update in June 2015
ECHA e-News is a weekly update from the European Chemicals Agency


OECD releases new data on nanomaterials – registrants asked to consider the information

The OECD has started the dissemination of hazard information on 11 nanomaterials in IUCLID format. The new information is the outcome of an experimental programme where 11 commercially viable nanomaterials have been used to generate results from 780 studies relating to their intrinsic properties. The work has already given significant input to the specific amendments to the existing test guidelines and generated numerous nano-specific (eco)toxicological data. It will continue to be a cornerstone of the work around risk assessment of nanomaterials.

Press release | ECHA's web page on nanomaterials

ECHA next week

11th Biocidal Products Committee meeting
16-18 June 2015

38th ECHA Management Board meeting
17-18 June 2015

ECHA will be closed for public holiday on 19 June

REACH fees adjusted for inflation

An amendment to the Fee Regulation has been published in the Official Journal of the European Union. It will adapt the fees and charges to the 2013 inflation (+1.5%).

News item | Official Journal of the European Union

Update to CLP Guidance document

ECHA has published a corrigendum of the Guidance on the Application of the CLP Criteria - Part 2 Physical Hazards and Part 3: Health Hazards. The corrigendum is to update the text in Part 2 Physical hazards and Part 3 Health hazards, following the end of the transitional period for the Fourth ATP of the CLP Regulation.

Guidance on the Application of the CLP Criteria

New intentions for risk management option analysis and informal hazard assessment published

The Public Activities Coordination Tool (PACT) has been updated with the publication of several new intentions for informal hazard assessment, one new intention for risk management option analysis (RMOA) development and one RMOA conclusion document.

Informal hazard assessment

14 intentions for carrying out hazard assessment for substances were added to the list. The newest intentions are displayed at the top of the PACT table with the inclusion date of 5 June 2015. Eight of the new entries are for persistent, bioaccumulative and toxic (PBT) properties, one for endocrine disrupting (ED) properties and four for both PBT and ED. In addition, one substance is added to the list for the hazard assessment of carcinogenic, mutagenic or toxic for reproduction (CMR) and ED properties.

One outcome document was also published - 3,7,11-trimethyldodeca-1,6,10-trien-3-ol, mixed isomers (EC 230-597-5). According to evaluating member state Austria, the substance is not considered to meet the persistent, bioaccumulative and toxic and/or very persistent and very bioaccumulative (PBT/vPvB) criteria.

Risk management option analysis

One new intention for risk management option analysis was notified by Sweden for the substance 4,4-isobutylethylidenediphenol (EC 401-720-1).

In addition, one conclusion document for hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC, EC 250-863-4) was published. Sweden concluded that there's no need to initiate further regulatory risk management action at this time.

PACT - RMOA and hazard assessment activities

Board of Appeal decision published regarding a request for animal testing following a testing proposal

The latest decision, in case A-001-2014, from the ECHA Board of Appeal concerns an Agency decision requesting an Extended One Generation Reproductive Toxicity Study (EOGRTS) and the third-party consultation procedure followed by the Agency during the evaluation of a testing proposal.

The Board of Appeal found firstly that the Agency had correctly followed the procedure required to collect information on the testing proposal from third parties.

However, the Board of Appeal found that the contested decision should be annulled as the Agency's request for an EOGRTS to be conducted did not take into account important information contained in the registration dossier of another registrant for the same substance. The Agency had not considered this information because of its application of a cut-off point, applied for reasons of administrative efficiency, for taking new information into account. As a result of the Agency's application of this cut-off point the Board of Appeal found that it was possible that the registrant may undertake animal testing unnecessarily. The Board of Appeal found that the Agency did not, in this particular case, take account of all the relevant facts and circumstances in balancing the need for administrative efficiency with the obligations placed on the Agency to ensure that testing on vertebrate animals is a last resort.

Decisions of the Board of Appeal

Survey on compliance control and cost of possible restriction on four classified phthalates – deadline extended

ECHA and the Danish authorities are currently considering a restriction on the four phthalates DEHP, BBP, DBP and DIBP in articles. As part of the assessment of the proportionality of the restriction, data on industry practices to ensure compliance with REACH restrictions on substances in articles, and in particular the phthalates, are being collected. Interested parties are invited to respond to the survey to collect up-to-date information on compliance control costs for the four phthalates by 24 June 2015.

Survey of compliance control and costs of possible restriction on four classified phthalates

Authorisation granted to Yara France

Yara France has been granted an authorisation for its use of diarsenic trioxide as a processing aid to activate the absorption and desorption of carbon dioxide by potassium carbonate from synthesis gas formed in the production of ammonia. The review period of the authorisation will run until 21 March 2017.

Adopted opinion | Official Journal of the European Union

Have your say on ECHA's publications

ECHA is planning to produce more electronic publications in the future. We encourage you to participate in our survey. This is your chance to help us improve our publication services to you for the coming years.

Give your feedback by 17 June 2015.

ECHA publications 2015 survey


The Regulatory Processes Involved in Acceptance of Non-Animal Tests webinar

10 June 2015, 3:00 pm BST (London)

The event is part of a series of webinars on alternative methods to animal testing and it is co-sponsored by PETA International Science Consortium and Chemical Watch. Derek Knight from ECHA will speak about regulatory acceptance from a scientific and procedural point of view, while Karin Kilian from the European Commission will explain the process for incorporating validated tests into the EU Test Methods Regulation.

Registration | Series of webinars

Introduction to OECD QSAR Toolbox webinar

17 June 2015, 11:00-14:00 Helsinki (EEST, GMT +3)

The webinar will provide an introduction to the OECD QSAR Toolbox and its functionalities. Two examples will cover endpoints which will be relevant for the REACH registration deadline in 2018 (e.g. skin sensitisation, aquatic toxicity). The Toolbox is the most comprehensive, widely recognised and freely available platform for data gap filling in regulatory hazard assessment, while avoiding tests. It is used for grouping chemicals into categories, identifying and filling (eco-)toxicological data gaps for the hazard assessment of chemicals.

Register | OECD QSAR Toolbox | Agenda

Seminar on Applications for Authorisation on 29-30 June

29-30 June 2015, Helsinki

ECHA is organising a seminar in collaboration with Cefic and Eurometaux to improve future applicants' knowledge of the authorisation application procedure. The main topics to be covered include the content requirements for applications, the public consultation on possible alternatives, the analysis of alternatives and socio-economic analysis, as well as the formats, manuals and tools for the application submission.

The registration to attend the seminar has closed but the event will be webstreamed.

Register | Seminar on Applications for Authorisation

REACH 2018 webinar: Know your portfolio and start preparing now – check out the agenda and register today

24 June 2015, 11:00-11:50 Helsinki (EEST, GMT +3)

This is the first webinar of a series focusing on practical information to successfully register by the deadline of 31 May 2018.

The webinar aims to give information to companies that do not have previous experience of registering chemicals under the REACH Regulation. It will give you a basic understanding of which substances in your portfolio need to be registered before the 2018 deadline, the required information and the main costs that need to be budgeted for that purpose. You will also get a clear indication on how to move forward and where to find further information. Finally, the webinar will include a Q&A session where we will address any outstanding issues related to the topic.

Register | Draft agenda | REACH 2018 web pages

Biocides Stakeholders' Day – programme published

1 September 2015, Helsinki

This year's conference will be split into three plenary sessions covering product authorisation: impact of Article 95 and Union authorisation, getting the help you need from our IT-tools and other available support. The day concludes with an update on upcoming regulatory developments.

Places to the conference are limited so register now to ensure yours!

The day is open to all and the content will be of particular relevance to European and national trade associations, SMEs, large companies, alternative suppliers and environmental, animal-welfare as well as health NGOs.

Event page | Programme | Register

10th Stakeholders' Day – give us your feedback

The 10th Stakeholders' Day welcomed nearly 200 participants to Helsinki on 27 May and a further 350 watched the event live through web-streaming. If you attended the event in person or through the stream, we very much welcome your feedback on the event. The feedback questionnaire is still open until Friday 12 June.

Event page | Give us your feedback

Ongoing consultations

Start: 24 April 2015
Deadline: 12 June 2015

1 testing proposal

Start: 20 May 2015
Deadline: 6 July 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: 5 May 2015
Deadline: 22 June 2015

2 CLH proposals

Start: 19 May 2015
Deadline: 3 July 2015

1 CLH proposal

Start: 2 June 2015
Deadline: 17 July 2015

2 CLH proposals

Start: 2 June 2015
Deadline: 3 August 2015

1 CLH proposal


Start: 17 December 2014
Deadline: 17 June 2015
1 restriction proposal

Start: 18 March 2015
Deadline: 18 September 2015
1 restriction proposal

Applications for authorisation

No ongoing consultations

Calls for comments and evidence

Start: 1 April 2015
Deadline: 11 June 2015

1 substance

Start: 24 April 2015
Deadline: 24 June 2015

1 substance

Start: 13 May 2015
Deadline: 15 July 2015

2 substances

Biocides consultation

No ongoing consultations

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