ECHA e-News - 3 December 2014



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

R4BP 3 - Register for Biocidal Products

New improved version of R4BP 3 now available

The newly released version of R4BP 3, the central hub through which all biocides applications are made, provides significant additions and improvements. Furthermore, for the authorisation of biocidal products the new release integrates data present in the Summary of Product Characteristics (SPC). This will require companies and competent authorities to use the new SPC format supported by the SPC editor, which was released by ECHA on 28 October 2014.

News alert | R4BP 3.2 support page | Q&As

ECHA next week

MSC-39 meeting
8-11 December 2014

Guidance on biocides legislation

ECHA has updated the Biocides Guidance web pages to reflect the new Biocidal Products Regulation (BPR) guidance structure. The pages include information on the development and status of the guidance documents and links to the published guidance documents, as well as an updated figure of the BPR structure and related pages. In addition, ECHA has published a corrigendum of Part A Information Requirements, dividing the first version of the guidance document into four respective volumes.

Guidance on biocides legislation

Updated guidance to support R&D and innovation

To support innovation, especially by SMEs, ECHA has published an update to its Guidance on Scientific Research and Development (SR&D) and Product and Process Orientated Research and Development (PPORD) simultaneously with a new Guidance in a nutshell on the same subject.

News alert | Guidance on SR&D and PPORD | Guidance in a nutshell on PPORD

Registry of Intentions updated


The Netherlands has sent an SVHC intention for Karanal (EC 413-720-9). The dossier is expected on 2 February 2015.


Sweden sent a CLH intention for bis(1-hydroxy-1H-pyridine-2-thionato-O,S)copper (EC 238-984-0). The dossier is expected on 30 December 2014. The Registry of Intentions was updated with two new submissions: nonadecafluorodecanoic acid (EC 206-400-3) submitted by Sweden and Penthiopyrad (CAS 183675-82-3) submitted by the UK.

Current SVHC intentions | Current CLH intentions | Submitted CLH proposals

Reminder to submit substance in article (SiA) notifications by 16 December 2014

ECHA reminds importers and EU producers of articles that the 16 December 2014 is the deadline for submitting the substance in article (SiA) notifications for the following four substances of very high concern (SVHCs) added to the Candidate List on 16 June 2014: cadmium chloride (EC number 233-296-7), sodium peroxometaborate (EC number 231-556-4), sodium perborate; perboric acid, sodium salt (EC number 239-172-9; 234-390-0), and 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear (EC number 271-093-5).

Companies are invited to verify if their articles meet the conditions for the notification obligation under Article 7 of the REACH Regulation. More information is available on our dedicated "Notification of substances in articles" webpage. The notification can be submitted either through the substance in article webform or through REACH-IT using IUCLID.

Notification of substances in articles | Webform & REACH-IT using IUCLID | Candidate List

Read-across assessment framework – next steps towards implementation

ECHA is preparing a systematic approach to assess read-across cases under dossier evaluation. The read-across assessment framework (RAAF) allows ECHA evaluators to assess the use of read-across in registration dossiers. It describes several different scenarios that cover the most important scientific aspects for using read-across. In its current form, the framework focuses on toxicity studies for mono-constituent substances and human health endpoints.

The framework concept was discussed with Member States, the Commission and accredited stakeholders at a workshop in October 2014. Among the topics were, for example, consistency of the scenarios, the stringency of assessment elements, identification of bias and terminology. ECHA will now integrate the findings of the workshop into the framework. Once this is complete, ECHA will communicate about the framework to stakeholders in 2015.

Experts WS on Read-Across Assessment with active support from Cefic-LRI | Summary of the Workshop on RAAF

ECHA's Board of Appeal publishes its latest decision

The subject of case A-005-2013 was how registrations are handled if there is an unresolved data-sharing dispute at the time of registration and by the time of the technical completeness check. The Appellant claimed that ECHA had unlawfully taken a decision granting a claimant in a data-sharing dispute permission to proceed with its registration, and to proceed to the technical completeness check, despite the fact that the registration was incomplete. The Board of Appeal found that ECHA had, in fact, not taken any such decision. The appeal was therefore considered to be inadmissible and was dismissed.

Decisions of the BoA

ENES 7 - documents published

The seventh meeting of the Exchange Network on Exposure Scenarios (ENES) took place on 18-19 November in Brussels. It focused on improving supply chain communication and the role of the REACH exposure scenarios.

Among the topics were e.g. improvements in downstream sector use maps and inputs for the registrants' chemical safety assessment on the condition of use of substances. An improved use maps template with guidelines was recently tested; a proposal to develop a template for providing input datasets for the worker exposure assessment was presented. Mixtures, the exposure scenario for communication (ESCom), chemical safety assessment and related upcoming guidance updates were also discussed.

The presentations and meeting documents are now available at the link below.

ENES 7 presentations and meeting documents


Webinar on mixture classification and communicating safe use of mixtures – last chance to register for the re-run

8 December 2014, 12:00 – 14:00 Helsinki Time (EST, GMT +2)

Due to the high demand, we will organise a re-run of the webinar that took place on 5 November. The video recording will be played and you will have the possibility to ask questions in writing to our specialists during this time. You can already check the presentations and the recording online.

The webinar covers the classification of mixtures and how information on their safe use can be communicated in the supply chain. It aims to help formulators and importers understand and implement their obligations according to the REACH and CLP regulations relating to mixtures.

Register for the re-run | Presentations | Recording

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: 21 October 2014
5 December 2014

3 CLH proposals

Start: 28 October 2014
12 December 2014

2 CLH proposals

Start: 13 November 2014
2 January 2015

1 CLH proposal


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

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

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