ECHA e-News - 29 April 2015

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

Biocidal Products Regulation

In situ generated biocidal active substances redefined

Active substances generated in situ have been redefined to specify the precursors from which the active substance is generated. Suppliers of active substances generated in situ from other precursors can now notify ECHA to have their precursor-active substance system included in the review programme.

News alert | In situ generated active substances | Substances with a redefined identity

New version of the Registry for Biocidal Products (R4BP 3) available

The new release of R4BP 3 allows product authorisation change requests in parallel and enhances synchronisation between related applications.

News item | R4BP 3.2 | SPC 1.2 editor

ECHA next week

ECHA will be closed for public holiday on 1 May

REACH 2018 webinar

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

Register | Draft agenda

ECHA Newsletter

Advice for registrants on skin sensitisation testing helps reduce animal tests

ECHA has published advice on using new OECD test guidelines related to skin sensitisation. The new non-animal test guidelines each address a specific key event in the adverse outcome pathway for skin sensitisation, describing the main biological steps in skin sensitisation. They are relevant for many registrants preparing for the 2018 REACH registration deadline and, if used correctly, can replace the need to use animal test methods.

News alert

April Newsletter online – you can now comment its content

In this issue, we have included interviews with industry experts and asked what advice they have for those preparing for the upcoming REACH and biocides deadlines. We also introduce a new functionality in the online version – you can now comment and rate the Newsletter content. To get started, all you need to do is create a user account on ECHA's website and sign-in. We look forward to getting your direct feedback on our articles.

As usual, the Newsletter is also available in PDF format on the Newsletter website.

Read the Newsletter | PDF version

Call for evidence for use of phthalates DEHP, DBP, BBP and DIBP in articles

ECHA and the Danish Environmental Protection Agency have launched a call for evidence to identify the current uses of the four phthalates in articles, the phthalate content and migration rates, as well as other relevant information for the preparation of an Annex XV restriction dossier.

The call is to support their joint work to investigate the need for a restriction, according to Article 69(2), on the placing on the market of articles containing the four phthalates. Interested parties are invited to respond by 24 June 2015. This call for evidence does not replace the public consultation organised by ECHA at the start of any restriction process (potentially March to September 2016 if a restriction proposal is submitted).

Calls for comments and evidence

Update to the list of substances potentially subject to compliance checks

ECHA has updated the list of substances that might be chosen for compliance checks with 58 new entries. To make the compliance check process more transparent, ECHA publishes the list which now includes 67 substances. It is updated a few times each year. ECHA published the list for the first time in January 2015 and has already started to work on most of those cases.

Substances potentially subject to compliance checks | Compliance checks

New RAC reference values for applications for authorisation now available on ECHA's website

Two notes on the dose-response relationships for the carcinogenicity of 2,2'-dichloro-4,4'-methylenedianiline (MOCA, EC 202-918-9) and oligomeric reaction products of formaldehyde with aniline (technical MDA, EC 500-036-1) agreed by the Committee for Risk Assessment (RAC) at their March meeting are now available on the ECHA website. These are non-legally binding reference values which RAC will use to evaluate applications for authorisation in a predictable and transparent manner.

Evaluating applications

Registry of Intentions updated

Substances of very high concern (SVHCs)

Sweden plans to submit an SVHC dossier on hexamethylene diacrylate (hexane-1,6-diol diacrylate; EC 235-921-9). The expected submission date is 3 August 2015.

Current SVHC intentions

Harmonised classification and labelling (CLH)

Three new CLH intentions were added: pentapotassium 2,2',2'',2''',2''''-(ethane-1,2-diylnitrilo)pentaacetate (EC 404-290-3), 1,4-dioxane (EC 204-661-8) and titanium dioxide, to be further specified (EC 236-675-5).

United Kingdom has submitted a CLH dossier for metofluthrin (CAS 240494-70-6) and France has submitted CLH dossiers on potassium permanganate (EC 231-760-3) and granulated copper, to be further specified (EC 231-159-6).

Current CLH intentions | Submitted CLH proposals

Updated Biocides Guidance document

ECHA has published by corrigendum an updated Biocides Guidance document for Volume III Human Health, Part B Assessment to add a Commission document on identification and evaluation of substances of concern in relation to human health endpoints. In addition, the document has been reformatted to improve the presentation and readability.

Guidance on biocides legislation

New pages on ECHA's transparency published

Transparency is one of ECHA's five core values, alongside Independency, Trustworthiness, Efficiency and Commitment to well-being. The new transparency webpage acts as a hub for Agency's transparency policies, dissemination practices, ECHA's decisions and how to get involved.

With regard to Independence, it is worth noting that the annual report of the Conflict of Interest Advisory Committee for 2014 is now also available on ECHA's website.

Transparency at ECHA | Annual report of the Conflict of Interest Advisory Committee for 2014


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

Improving the use of REACH and CLP information in the supply chain

The presentations from the workshop on exploring new ways to use REACH and CLP information to enhance the safe use of chemicals at industrial sites are now available.

Event page and presentations

10th Stakeholders' Day

27 May 2015, Helsinki

Only 2 days left to register. Online registration closes on 1 May.

If you have already registered but you are no longer able to attend, please inform us of your cancellation to free your place for other interested participants. You can inform us by sending an email to: A live webstream will be available and a link will be published on the ECHA homepage on the morning of the event.

Register | Event page | Programme | List of speakers

Biocides Stakeholders' Day

1 September 2015, Helsinki

The conference takes place on 1 September, which is the three-year anniversary of the entry into operation of the Biocidal Products Regulation (BPR).

The programme will focus on case studies and experiences from companies. There will also be presentations on the regulation and available tools and support.

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 as well as health NGOs.

Online registration is open. There are a limited number of places available on a first-come, first-served basis; so register now to ensure yours.

Event page | Register

Ongoing consultations

Start: 16 March 2015
Deadline: 30 April 2015

15 testing proposals

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 (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: 27 March 2015
Deadline: 11 May 2015

3 CLH proposals

Start: 9 April 2015
Deadline: 26 May 2015

1 CLH proposal

Start: 21 April 2015
Deadline: 5 June 2015

1 CLH proposal


Start: 18 March 2015
Deadline: 18 May 2015
1 consultation on SEAC draft opinion

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 (new)

Biocides consultation

No ongoing consultations

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