ECHA e-News - 20 May 2015



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

Dossier evaluation

How to address the information requirement on pre-natal developmental toxicity

Registrants of the highest volume chemicals are invited to check that the information on pre-natal developmental toxicity (PNDT) is adequately addressed while avoiding unnecessary animal testing.

More information on PNDT studies can be found in REACH annexes IX and X and in the relevant guidance. ECHA has published information on the adaptation rules in Chapter R7a of the Guidance on Information Requirements and Chemical Safety Assessment. Endpoint specific guidance is being updated and is expected to be published in July 2015.

News alert

ECHA next week

ECHA will be closed for public holiday on 25 May

10th Stakeholders' Day
27 May

REACH 2018 webinar

Know your portfolio and start preparing now
24 June 2015, 11:00-11:50 (EEST, GMT +3)

Register | Draft agenda

New CLH consultation launched on reaction mass of 5 or 6 alkylphenol substituted benzotriazol isomers

ECHA has launched a 45-day public commenting period on the harmonised classification and labelling (CLH) proposal for reaction mass of: isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-dodecylphenol isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-5,6-didodecyl-phenol. n = 5 or 6 isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-tetracosylphenol (EC Number 401-680-5).

The dossier submitting Member State, Germany, is proposing to remove the current harmonised classification for environmental hazards. The hazard class "hazardous to the aquatic environment" is open for commenting during the public consultation. The final date for submitting comments for the substance is 3 July 2015.

Current CLH consultations

Registry of Intentions updated

Harmonised classification and labelling (CLH)

Five dossiers for harmonised classification and labelling were submitted for the following substances: spiroxamine (ISO) (CAS 118134-30-8), nicotine (ISO) (EC 200-193-3), pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate (EC 205-391-3), propane-1,2-diol (EC 200-338-0) and pyroxsulam (ISO) (CAS 422556-08-9).

Submitted CLH proposals

Orphan biocidal product authorisations and applications: Member States will soon contact companies

To address one of the issues resulting from the migration between R4BP2 and R4BP 3, Member States will soon contact all companies with orphan existing authorisations and on-going applications for biocidal products. Orphan authorisations are those for which the unique identifier of the future authorisation holder is missing from the Registry for Biocidal Products (R4BP 3).

Member States are asked to provide ECHA with updated information regarding all of these orphans in the database by 29 May 2015. Member State competent authorities will therefore contact the concerned companies directly. Once the currently missing information is available, ECHA will correct the entries in the database. This is expected to be completed by mid-June 2015.

News item

Co-opted members of RAC and SEAC:  call for expression of interests

- Experts in occupational hygiene and chemical exposure assessment
- Experts in socio-economic analysis

(Deadline: 4 June 2015, 12:00pm)

The Agency's Committee for Risk Assessment (RAC) and the Committee for Socio-economic Analysis (SEAC) are tasked to prepare and adopt opinions on applications for authorisations as set out in Title VII of the REACH Regulation.

The Agency foresees a peak workload on evaluating applications for authorisation from late 2015 through to 2016. It is therefore opening a call for co-opted members for RAC and SEAC. Applicants should express their interest on ECHA's website by 4 June 2015.

Call for expressions of interest | News alert

Measuring REACH and CLP Enforcement - new study published

The European Commission published a report on a study proposing 50 enforcement indicators for regulations on chemicals. The conclusions of the study will now be discussed with Member States, national enforcement authorities and the Forum.

DG GROWTH website | Report | Enforcement Forum


OECD QSAR Toolbox webinar

17 June 2015, 11:00-13:00 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

Seminar on Applications for Authorisation in June

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.

Register | Seminar on Applications for Authorisation

10th Stakeholders' Day – one week to go!

27 May 2015, Helsinki

We will be welcoming nearly 300 participants to this year's Stakeholders' Day conference next Wednesday 27 May. This year's event features keynote presentations from ECHA's directors and a wealth of practical information, best practice and advice for companies from our stakeholders. The day is split into three plenary sessions: REACH 2018, improving dossier quality and risk management.

If you are unable to attend in person, the conference will also be webstreamed and you will be able to submit your questions to the Q&A panel remotely. Instructions for joining the stream and to submit your questions will be visible on the morning of the event on the ECHA homepage.

If you have registered but you are no longer able to attend, please inform our event team at: to free your place for other interested participants.

Event page | Programme | List of speakers

2015 Helsinki Chemicals Forum - Last chance to register!

28-29 May 2015, Helsinki

Register to the Helsinki Chemicals Forum taking place from 28 to 29 May. Registration is open until Thursday 21 May. If you are already attending the ECHA Stakeholders' Day conference on 27 May, you are entitled to a reduced fee of 650€. Keynote speakers at the event include Geert Dancet from the European Chemicals Agency (ECHA), Antti Peltomäki, Deputy Director General and Klaus Berend, Head of Unit from the European Commission. A workshop "The business case for sound chemicals management" will also be organised by Chemical Watch at the end of the event.

The Helsinki Chemicals Forum is an independent forum engaging international authorities, industry leaders, NGOs, academics, the media and other interested parties in an open dialogue on key issues of global relevance regarding chemicals management and the control of chemicals safety.

Further information | Programme | Register

Ongoing consultations

Start: 17 April 2015
Deadline: 4 June 2015

28 testing proposals

Start: 20 April 2015
Deadline: 8 June 2015

1 testing proposal

Start: 24 April 2015
Deadline: 12 June 2015

1 testing proposal

Start: 20 May 2015
Deadline: 6 July 2015

7 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: 9 April 2015
Deadline: 26 May 2015

1 CLH proposal

Start: 5 May 2015
Deadline: 4 June 2015

1 CLH proposal

Start: 21 April 2015
Deadline: 5 June 2015

1 CLH proposal

Start: 5 May 2015
Deadline: 22 June 2015

2 CLH proposals

Start: 19 May 2015
Deadline: 3 July 2015

1 CLH proposal (new)


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: 28 May 2015

1 substance

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