Appreciating the challenges lying ahead of companies that have the obligation to register substances by 31 May 2018, in particular those that fall in the 1-10 tpy band, ECHA have produced a document on the determination of substances meeting Annex III criteria. Annex III lays out specific criteria that if 1-10 tpy registrants can prove they do not meet for a given substance, they need only provide information on physico-chemical endpoints, thus reducing cost and resource required to register such substances. This may also lead to the avoidance of animal testing for the low hazard and low risk phase-in substances.
Clearly, meeting the derogation outlined above is preferable although proof of which is not easily achieved and can be resource intensive, requiring significant expertise. The document produced by ECHA indicates an inventory of substances that meet the Annex III criteria (and hence don't meet the derogation) will be published along with a template for providing evidence in support of the exemption in addition to other resources aimed at easing the burdens.
REACH: Draft Evaluation Decisions (5 April 2016)
The results of 48 substances evaluated under the Community Rolling Action Plan (CoRAP) have been released by ECHA. 32 of the substances have been deemed to require further information in order to properly identify what, if any, risk management measures are appropriate. Active registrants with full submissions (as opposed to intermediate) will be required to coordinate their activities upon receipt of the draft decision issued by ECHA. One point of contact (usually the Lead Registrant) will then need to provide comments to the agency on the draft proposal.
It is advised to liaise with the rapporteur Member State as early as possible in the process and open up communication channels. The draft decisions will be issued in the last week of April and registrants will have 30 days from the issuance to provide comments to be taken into consideration before the final decision is made. In view of the recent Implementing Act on Joint Submission of Data and Data Sharing, Article 4(6), registrants that cease manufacture or import before the issuance of the final decision are unlikely to be liable for sharing the costs of further testing / information generation required in the draft proposal. Two substances evaluated under CoRAP failed to meet the minimum required end points of the registrations and will be subject to a compliance check. A total of 14 substances were deemed to not require any further testing in order to identify the most appropriate risk management measures.
REACH: Important ECHA Board of Appeal (BoA) decision (17 March 2016)
Another demonstration of the BoA’s impartiality from ECHA, a recent decision on a case regarding ECHA providing a registration number to allow a company to submit a registration outside of the existing joint registration. The appellant, the Lead Registrant for charcoal, has been successful in claiming this was a breach of the One Substance, One Registration (OSOR) principle and as opposed to ECHA’s stance that the individual submission was complete, the BoA in fact found the registration to be incomplete.
Due to the implications on previous registrations that are not compliant with the OSOR principle, the significance of this decision could mean that ECHA may need to adopt a different approach towards how these legacy registrations will now be addressed. Software no longer permits the submission of registrations outside of a joint submission if one already exists, but this is a recent development.
REACH: Test Methods Regulation Adaptation to Technical Progress (ATP) (7 March 2016)
The new ATP to the Test Methods Regulation (EC) 440/2008 in accordance with REACH has been published in the Official Journal. The update has been instigated by the new and updated test methods adopted by the Organisation for Economic Cooperation and Development (OECD). A new HPLC method for the determination of the partition coefficient (P), 11 new and three updated test methods for ecotoxicological assessment, and five new methods for determination of environmental behaviour and fate are included in the ATP.
REACH: Review of ECHA’s Substance Evaluation (SEv) (18 February 2016)
A recent review of the Compliance CHeck (CCH) and SEv has been undertaken by independent consultants to assess the processes. It was found that improvements could be made in certain aspects, by addressing: short deadlines that parties struggle to comply with; communication of the time scale available to registrants for decision making; streamlining CoRAP so that the substances that matter are sufficiently considered in the process; ensuring CCH and SEv are complimentary to each other by using CCH as a tool to fill data gaps potentially of benefit to SEv, amongst other suggestions.
REACH: Registrations in breach of ‘One Substance One Registration’ are no longer possible (1 February 2016)
After an update to REACH-IT, it is no longer possible to submit a registration separate to one that already exists for the same substance. Separate registrations for the same substance can only be made for different types of registrations ie full and intermediate, the One Substance One Registration (OSOR) principle applies to each of these registration levels. This update is in line with the Implementing Act on Joint Submission of Data and Data Sharing Implementing Act on Joint Submission of Data and Data Sharing, which entered into force on 26 January 2016, and lays out the OSOR as a provision.
It is still possible to fully opt-out of a joint registration and therefore not engage in data sharing activities with the Lead Registrant. The criteria for such action remains the same: if the joining registrant finds the price of data to be disproportionate, disagrees with the LR’s selection of the data, or submitting the information would lead to disclosure of information that would lead to substantial commercial detriment. In such circumstances dossiers will still be submitted under the same registration, but all or some of the information can be submitted individually. It should be noted that this course of action automatically qualifies the registration dossier for Substance Evaluation and that every effort should be made to come to an agreement on data sharing, especially in the case of avoiding unnecessary vertebrate animal testing.
REACH: Publication of Implementing Act (6 January 2016)
The Implementing Act on Joint Submission of Data and Data Sharing in accordance with REACH has been published in the official journal and will enter into force on the 20th day after its publication on the 6 January 2016. Containing provisions that build on guidelines published by the Director’s Contact Group, the new act lays out provisions to facilitate the transparency, non-discriminatory and fairness principles that are in the REACH regulation. In light of the new regulation, the Director’s Contact Group will revise its guidelines.
The act will have significant impacts for those working in and around REACH, with those currently and previously involved in compiling registration dossiers being most affected. One of the most notable implications of the act is some of the provisions apply retroactively, therefore impacting previous registrations. A primary provision of the act is “One Substance One Registration”, not explicitly stipulated in the REACH text (although is a principle running throughout it) but is now written into the law. The next REACHReady Review will include a more detailed assessment of the new regulation.
REACH: Five substances added to the Candidate List (17 December 2015)
ECHA have announced the addition of 5 out of the 7 recommended substances to be included in the Candidate List, which now totals at 168 entries. The substances and reasons for inclusion are as follows:
1) 1,3-propanesultone (EC no 214-317-9): carcinogenic
2) 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327) (EC no 223-383-8): vPvB
3) 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350) (EC no 253-037-1): vPvB
4) Nitrobenzene (EC no 202-716-0): Toxic for reproduction
5) Perfluorononan-1-oic acid and its sodium and ammonium salts (EC no 206-801-3): PBT, toxic for reproduction
If your business is directly affected by any of these substances, you may be under obligations regarding notification and communication for the presence in articles, communication through SDS and others. Additionally, now these substances are candidates for the authorisation list, there is a chance they will ultimately be subject to authorisation – potentially resulting in your business or supply chain discontinuing use of the substance.
Upon receipt of comments on hexamethylene diacrylate has not been added to the Candidate List, the Member State Committee did not reach a unanimous decision for the inclusion in the CL and so it has not been added.
The Annex XV dossier submitted for dicyclohexyl phthalate was withdrawn following public consultation.
Gold subscribers can access REACHReady’s searchable Candidate List database here.
REACH: REF-3 project report (11 December 2015)
The report for the REACH-EN-FORCE-3 project, which focused on companies’ compliance with registration and was orchestrated by ECHA’s Forum for Exchange of Information on Enforcement, is now available. Of the inspected companies, a total of 13% did not meet their registration obligations in some manner and of that 13%, 9% of companies were incompliant due to failing to make a registration where one was required. Small to medium size enterprises were more often not compliant with REACH registration obligations, in contrast to larger companies.
Overall, the report has deemed the findings to signify a very high rate of non-compliance. According to the report, Only Representatives are the most likely to be non-compliant (poor record keeping is exemplified, amongst suggested reasons), followed by Importers.
REACH: Authorisation granted for trichloroethylene (24 November 2015)
An authorisation has been granted to a wax fabric designing company - Vlisco, Netherlands - for trichloroethylene. Two uses have been granted: 1) as a solvent for the removal and recovery of resin from dyed cloth and 2) as a solvent in a process to recover and purify resin from process water.
The application was granted on the grounds that no technically or economically feasible alternatives are known and the socioeconomic analysis yielded the benefits outweighed the risk to human health. A 12 year R&D plan has been included to search for suitable alternatives.
REACH: Enforcement of internet chemical sales and the ECJ ruling on the interpretation of articles (19 November 2015)
The Forum for Exchange of Information on Enforcement will commence a pilot project in 2016 with the objective of enforcing internet sale of substances and mixtures with regard to legal provisions. Particular aspects under scrutiny may include Safety Data Sheets, CLP compliant labels etc. to ensure the customer has sufficient information for safe use.
In 2017 the Forum also intends to begin a project concerning the European Court of Justice ruling on 10 September 2015 (in favour of “articles within articles”) in relation to notification and communication duties, Articles 7(2) and 33 respectively, for SVHCs present in articles in concentrations greater than or equal to 0.1% (w/w).
Biocides: Manual of Decisions repealed (1 October 2015)
The Manual of Decisions regarding the Biocidal Products Directive (BPD) has been repealed. Companies who previously considered their product exempt from the BPD on the basis of this manual are advised to check with their national Biocides Competent Authority Helpdesk if the product is now in scope of the BPR. Where a product is newly considered to be biocidal within the meaning of the BPR, the company should declare its interest to notify the relevant active substance/product-type combination for inclusion in the Review Programme. The declaration must be made via the ECHA website here by 3 October 2016.
ECHA will subsequently publish a list of notifiable active substance/product-type combinations and companies will have six months to make the relevant notifications. The full application for active substance/product-type approval must then be submitted within two years.
REACH: Draft CoRAP update published (28 October 2015)
ECHA has published a draft update to the Community Rolling Action Plan (CoRAP). According to the proposal, Member States would carry out evaluation on 138 substances during the 2016-18 period; 53 of these substances are newly proposed for CoRAP listing. The draft update provides substance names and CAS and EC numbers, together with the contact details for the proposed evaluating Member States, and brief details of the initial area of concern.
ECHA's Member State Committee must now discuss the draft update and will prepare its opinion in February 2016. ECHA will then adopt the 2016-18 CoRAP, publishing it in March 2016.
"REACH Registration: Are you Ready for 2018?" webinar: recording available
On 23 September, REACHReady was pleased to present the technical content of a "REACH Registration: Are you ready for 2018?" webinar. Moderated by the Royal Society of Chemistry, the one-hour webinar provided insight into some of the unique challenges posed by the final deadline, particularly for companies with no previous registration experience.
During the presentation, poll questions were used to find out how many substances participants expected to register for the 2018 deadline, to understand their biggest concerns regarding substance identity, and to gauge their familiarity with IUCLID. An overwhelming majority of participants said they were expecting to register just a few (1-10) substances, but few felt comfortable with IUCLID and many felt that they would find identifying impurities the biggest challenge when defining their substance.
A recording of the webinar is available here.
REACHReady is proud to be delivering a one-day follow-up workshop on REACH 2018 in collaboration with the Royal Society of Chemistry on 17 November. Click here for more information.
REACH: ECJ Ruling upholds Opinion on SVHCs in articles (10 September 2015)
Today, the European Court of Justice upheld the Opinion of the Advocate-General in the Case C-106/14 on substances of very high concern in articles. The Court ruled that each of the articles incorporated as a component of a complex product is covered by the relevant duties to notify and provide information when they contain an SVHC above 0.1% by weight. It also clarified, however, that the complex article producer's notification duty does not extend to the component articles which were produced by a third party (i.e. upstream supplier).
Regarding the communication of SVHCs in the supply chain, the text of the Ruling states that "Article 33 ... must be interpreted as meaning that ... it is for the supplier of a product one or more constituent articles of which contain(s) a substance of very high concern identified in accordance with Article 59(1) of that regulation in a concentration above 0.1% weight by weight of that article, to inform the recipient and, on request, the consumer, of the presence of that substance by providing them, as a minimum, with the name of the substance in question".
For the notification obligation, the Ruling states that "Article 7(2) ... must be interpreted as meaning that ... it is for the producer to determine whether a substance of very high concern ... is present in a concentration above 0.1% weight by weight of any article it produces and, for the importer of a product made up of more than one article, to determine for each article whether such a substance is present in a concentration above 0.1% weight by weight of that article".
REACH: Consultations open on seven SVHC proposals (2 September 2015)
Substances which are added to the Candidate List of SVHCs undergo public consultation prior to their inclusion. Consultations are now open on seven SVHC proposals:
- 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327)
- 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350)
- Dicyclohexyl phthalate
- Hexamethylene diacrylate (hexane-1,6-diol diacrylate)
- Perfluorononan-1-oic acid and its sodium and ammonium salts
The consultation period is open until 15 October 2015, allowing interested parties to comment on the proposals. In particular, ECHA welcomes comments on substance identity, on PBT or vPvB properties and on properties giving rise to an equivalent level of concern. However, comments questioning harmonised classification and labelling per Annex VI to CLP will not be considered in the SVHC identification process.
We expect the next Candidate List update in December 2015.
REACH: ECHA SDS guidance updated (18 August 2015)
ECHA has published an update to the Guidance on the compilation of safety data sheets. This version, 3.0, takes into account the end of the transitional period for labelling mixtures according to the Dangerous Preparations Directive (DPD) and the need to indicate the classification of their components according to the Dangerous Substances Directive (DSD), as well as the full implementation of CLP. The updated Guidance also takes into account the recent changes in the REACH Annex II legal text arising from the new Regulation (EU) 2015/830.
Additionally, minor linguistic corrections were made to the English language version, and out of date information has been deleted.
Access the updated Guidance here.
REACH: ECHA's sixth recommendation for Authorisation (1 July 2015)
ECHA has made its sixth recommendation on substances to be added to Annex XIV, the Authorisation List. Of the 22 SVHCs listed in the draft recommendation, 15 Candidate-Listed substances with high volumes and widespread uses have been proposed to be subject to Authorisation.
The list of substances, which includes certain phthalate plasticisers, boric acid, n-propyl bromide, coal tar pitch, and 4-nonylphenol ethoxylates (branched and linear), is available here. Lead compounds not included in the final recommendation may be considered again in future rounds of inclusion.
The final decision on the inclusion of these 15 substances in Annex XIV and any transitional periods - namely, latest application and sunset dates - will be taken by the European Commission, in collaboration with the European Parliament and Member State representatives.
Presentations from the Regulatory Theatre at Chemspec Europe, Cologne (24 & 25 June 2015)
The annual European exhibition for the fine, custom and speciality chemicals market celebrated its thirtieth year with a show in Cologne over 24 & 25 June 2015 which recorded record-breaking visitor attendance. During the show REACHReady organised a series of free-to-attend talks delivered by a range of technical experts, including ECHA, on topics regarding legislation affecting those aiming to comply with chemical regulations both inside and outside of Europe. For further details of all the presentations and to download copies of the slides please visit our dedicated page.
REACH: ECHA updates Candidate List of SVHCs (15 June 2015)
has added two substances of very high concern to the Candidate List,
taking the total number of SVHCs to 163. The first of the two new
entries comprises a series of mixed alkyl diesters where these substances contain
dihexyl phthalate at 0.3% and above; they were identified as
SVHCs due to their reprotoxic effects. The second substance is a group entry
covering certain very persistent, very bioaccumulative (vPvB)
substances, and includes the aroma compound karanal.
REACHReady's SVHC database has been updated to reflect the changes and contains information on their common uses.
REACH: Update to Annex II on SDS requirements published (29 May 2015)
Two conflicting amendments of Annex II to REACH were due to come into force simultaneously on 1 June 2015, one made by Article 59(5) of the CLP Regulation and the other by Commission Regulation (EU) No 453/2010. A new Commission Regulation, EU 2015/830, has been published to clarify these amendments. In addition, a number of small changes recently adopted into the GHS are also reflected into the new regulation.
The measures apply from 1 June 2015; however, recipients who received a SDS before 1 June may continue to use it until 31 May 2017, unless a mandated update is required.
Access the new regulation here
BPR: In situ generated active substances redefined (28 April 2015)
Some biocidal products work not through a direct biocidal action of any component substance but due to an active substance they generate at the point of use. Such active substances are called 'in situ generated'. Previously, active substance evaluation did not cover consistently both the precursors and the in situ generated active substances. Therefore, the latter have been redefined to refer to both the substance generated in situ and the precursors. The aim of this redefined identity is to improve consistency in the evaluation and ensure that potential risks of both the precursor(s) and the in situ generated active substance are assessed.
There may be situations where other precursors are used by industry and which are not in the Review Programme. Companies may notify ECHA by 27 April 2016 if they wish to have their precursor-active substance combination included. However, notification is only possible where the combination is not already covered by the new identity; a list of combinations open for notification is available here.
Draft decisions due following evaluation of 51 substances (30 March 2015)
Last year, in accordance with the Community Rolling Action Plan (CoRAP) for 2014-2016, 51 registered substances were evaluated by 20 Member States. For 40 of those substances, the evaluating Member States need more information to clarify the suspected risks; the Member States have prepared draft decisions which ECHA intends to send to the relevant registrants on 4-8 May 2015. (Please note that this week contains public holidays for some EU countries, including the UK.)
Registrants will have 30 days to comment on the draft decision and they should monitor their REACH-IT accounts for the formal invitation. Registrants are encouraged to work together and to 'speak with one voice', appointing a Registrants' Contact Point to send consolidated comments on the draft decision received.
For 11 of the evaluated substances, Member States have not prepared draft decisions and no registrant consultation is required. A conclusion document will be submitted within four months of the end of the evaluation period, which will subsequently be published on the ECHA website.
ECHA has published a list of the 39 substances with draft decisions subject to commenting; registrants of di-tert-butyl 3,3,5- trimethylcyclohexylidene diperoxide (EC 229-782-3) already received the draft decision last year.
REACH Evaluation Report 2014 published (26 February 2015)
has published its annual report on Evaluation, highlighting common
deficiencies in dossiers and making recommendations to registrants.
The report indicates that, in 2014, the focus of dossier evaluation shifted from compliance checks to the examination of testing proposals submitted in registration dossiers. There were 770 proposals submitted for the 2013 deadline, which ECHA must examine by 1 June 2016. Additionally, testing proposals for non-phase-in substance registrations were also submitted in 2014, and some previous examinations were ongoing. A total of 239 testing proposals were examined in 2014 and 129 decisions were taken: 112 accepted the proposed tests, 16 modified at least one of the tests proposed, and one rejected the proposed testing.
During 2014, a total of 283 compliance checks (new cases) were concluded by ECHA, of which 61% led to a draft decision. The Evaluation Report, however, does note that this figure may not be representative of the whole registration database as selection criteria are used to find dossiers likely to have compliance issues, and only a small proportion are selected at random.
Common shortcomings were in relation to substance identity and physicochemical properties, as well as exposure assessment and risk characterisation, pre-natal developmental toxicity studies, and sub-chronic toxicity studies. Existing and future registrants are advised to use proactively the key recommendations in the Evaluation Report to improve dossier quality, especially in light of the new dossier evaluation strategy.
Non-confidential details of dossier evaluation decisions can be found on the ECHA website, and ECHA's Evaluation Report 2014 can be accessed here.
Introduction of Extended One-Generation Reproductive Toxicity Study (23 February 2015)
Commission Regulation (EU) 2015/282 regarding the Extended One-Generation Reproductive Toxicity Study (EOGRTS) has been published in the Official Journal of the EU. This Regulation amends Annexes VIII, IX and X from 13 March 2015.
EOGRTS is a new test method developed to assess the reproductive toxicity of chemical substances. It was adopted by the Organisation for Economic Cooperation and Development (OECD) in July 2011.
According to the new Regulation, EOGRTS offers a number of advantages over the two-generation reproductive toxicity study in its basic configuration. However, where justified, registrants may propose, and ECHA may request, information from additional, independent modules regarding second filial generation, developmental neurotoxicity (DNT) and developmental immunotoxicity (DIT).
ECHA's strategy on dossier evaulation (28 January 2015)
ECHA has published its new compliance check strategy to help improve transparency and efficiency in dossier evaluation. Of particular note is the list of substances potentially subject to compliance checks in 2015. The strategy will focus mainly on eight key endpoints: aquatic toxicity (long-term), bioaccumulation, biodegradation, carcinogenicity, genotoxicity, pre-natal developmental toxicity, repeated-dose toxicity, and reproduction toxicity.
As part of the strategy, ECHA has also clarified deadlines for dossier updates to be taken into account under dossier evaluation: registrants will have 60 days to update their dossier where they receive a draft decision on a testing proposal; in the case of compliance checks, ECHA will no longer take into consideration updates made after the draft decision on a compliance check has been issued to the registrant.
Second Commission decision on Authorisation (22 December 2014)
The European Commission has taken a decision on the application for authorisation made by Sasol-Huntsman GmbH & Co. KG. This application concerns the use of dibutyl phthalate as an absorption solvent in the closed-system manufacture of maleic anhydride. The decision of 18 December states that the risk is adequately controlled and at present there are no suitable alternatives. The review period will expire on 21 February 2027.
The European Commission has published a list of authorisation decisions adopted; the document also includes information on the applications on which an opinion has been adopted by ECHA's Risk Assessment and the Socio-Economic Analysis Committees (RAC and SEAC).
ECHA updates Candidate List (17 December 2014)
Today, ECHA has added six substances to the Candidate List of Substances of Very High Concern (SVHCs), taking the total to 161:
- Cadmium fluoride
- Cadmium sulphate
- 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320)
- 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328)
2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE)
- reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE)
Companies supplying these substances alone, in mixtures or in articles may have legal obligations resulting from their inclusion in the Candidate List. To help our subscribers identify products likely to contain these newly identified SVHCs, we will shortly update our "common uses" document, available to our Gold and Silver subscribers.
ATP to CLP on liquitabs (8 December 2014)
A Commission Regulation laying down additional packaging and labelling provisions for single-use liquid consumer laundry detergents in soluble packaging - commonly known as liquitabs - has been published. This ATP to the CLP Regulation adds a section 3.3 to Annex II on special rules for labelling and packaging of certain substances and mixtures. The new section sets out specific requirements for the soluble packaging, including the use of an aversive agent, the outer packaging and its labelling.
This ATP will apply from 1 June 2015.
New enforcement project to focus on restriction (10 November 2014)
The Forum for Exchange of Information on Enforcement coordinates a network of Member State authorities responsible for enforcement. As part of that role, the Forum proposes and coordinates harmonised projects across the EU, facilitating a common approach to enforcement in key areas of the Regulation. At its recent plenary meeting, the Forum decided to make enforcing REACH Annex XVII restrictions its next major project.
According to the ECHA Press Release, the scope of the project, together with the individual restrictions to be covered, will be confirmed in early 2015. Inspections are expected to take place in 2016 and the final report should be available in 2017.
If you supply articles and are concerned about the growing list of restrictions in Annex XVII, why not come to our next Managing REACH for Suppliers of Articles: How Compliant Are you? workshop? Contact us for more information!
Relationship between REACH and the Cosmetics Regulation (27 October 2014)
Substances in cosmetic products are not necessarily exempted from REACH or registration. In order to comply with REACH, some testing may be necessary as a last resort. However, the Cosmetics Regulation (1223/2009) prohibits the placing on the market of cosmetic products where animal testing has been carried out on the ingredients or the final formulation. Therefore, in cooperation with ECHA, the European Commission has clarified the interface between the Cosmetics Regulation and REACH regarding animal testing:
- Registrants are permitted to perform animal testing, as a last resort, for all environmental endpoints;
- Registrants of substances that are used for a number of purposes, and not solely in cosmetics, are permitted to perform animal testing, as a last resort, for all human health endpoints;
- Registrants of substances that are exclusively used in cosmetics may not perform animal testing to meet the information requirements of the REACH human health endpoints, with the exception of tests that are done to assess the risks to workers exposed to the substance. Workers in this context, refers to those involved in the production or handling of chemicals on an industrial site, not professional users using cosmetic products as part of their business (e.g. hairdressers).
Registrants of substances used exclusively in cosmetic products must still provide the required information using alternative methods such as read-across or QSAR.
Biocides Review Programme published (10 October 2014)
Commission Delegated Regulation (EU) No 1062/2014 has been published in the Official Journal of the EU. This Regulation lays down the rules of the work programme referred to in the BPR for the systematic examination of all existing active substances. Commonly known as the updated Review Programme, it will enter into force at the end of October and Regulation (EC) No 1451/2007 will be repealed.
Please note the list of substance/product-type combinations included in the Review Programme on 4 August 2014, which is found in Annex II.
Access the Regulation.
Public Activities Coordination Tool (26 September 2014)
To improve transparency of the approach to regulatory risk management, the ECHA website now lists the substances under consideration by the authorities for measures such as restriction, authorisation or harmonised classification and labelling. Such advance notice helps to raise awareness of these substances of potential concern, allowing industry and other stakeholders to prepare for possible future public consultations.
The Public Activities Coordination Tool (PACT) lists substances for which a 'Risk Management Option Analysis' (RMOA)' is complete, on hold or under development since the start of the implementation of the SVHC Roadmap in 2013.
The tool currently shows 80 substances including, for example, beryllium, methanol, six nickel compounds and sulphuric acid where the RMOA is under development. The table can be sorted by substance identifier, scope of the RMOA, authority responsible for the RMOA, status of the RMOA conclusion and suggested follow-up measures. Once the RMOA conclusion is finalised the document is made available under the 'details' link.
Consultation on SVHC proposals (4 September 2014)
A 45-day public consultation opened on 1 September 2014 on ECHA’s proposals to identify six new substances of very high concern (SVHCs) and to include additional reasoning for four existing Candidate List phthalates. The newly proposed substances comprise:
- two multi-constituent dioctyltin substances, DOTE and the reaction mass DOTE:MOTE, for their reprotoxic properties (Austria);
- cadmium fluoride and cadmium sulphate for their carcinogenic, mutagenic and reprotoxic properties, and for those leading to an equivalent level of concern regarding human health (Sweden);
- two nitrogen-containing heterocycles used as UV stabilisers, UV-320 and UV-328, for their PBT and vPvB properties (Germany).
Interested parties have until 16 October to comment on the proposals.
If agreed, these substances are likely to be added to the Candidate List in December 2014, taking the total number of SVHCs to 161. REACHReady's subscribers will have access to information, via our website, on the common uses of any newly identified SVHCs and the existing Candidate List substances.
22 Substances prioritised for Authorisation (1 September 2014)
ECHA has launched a public consultation on its draft sixth recommendation to include boric acid and 21 additional substances in Annex XIV to REACH. These substances have been prioritised by ECHA for Authorisation based on an assessment of registration data and other available information on applications, usage and hazards. The following substances are included in the draft proposal:
- Four boron substances: Boric acid; Disodium tetraborate, anhydrous; Diboron trioxide; Tetraboron disodium heptaoxide, hydrate;
- Seven lead compounds: Acetic acid, lead salt, basic; Lead monoxide; Lead tetroxide; Pentalead tetraoxide sulphate; Pyrochlore, antimony lead yellow; Silicic acid, lead salt; Tetralead trioxide sulphate;
- 4-Nonylphenol, branched and linear, ethoxylated;
- Seven phthalates: Diisopentylphthalate; 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich; 1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters; 1,2-Benzenedicarboxylic acid, dipentylester, branched and linear; Bis(2-methoxyethyl) phthalate; N-pentyl-isopentylphthalate; Dipentyl phthalate.
Interested parties are invited to comment on the draft recommendation using the webforms linked from the consultation web pages. This information, which could include details of uses stakeholders would like to see exempted, will be used to assess and, if necessary, refine the recommendation. According to its Press Release, ECHA expects a subset of the 22 prioritised substances to be selected for its final recommendation to the European Commission. Following receipt of ECHA's final recommendation, the Commission will decide which substances to include in the Authorisation List.
Information on possible socio-economic consequences of inclusion of these substances in Annex XIV may also be provided, in this case to the Commission, again via the relevant webforms on the ECHA website.
The consultation closes on 30 November 2014.
Nine new substances added to 'Authorisation List' (19 August 2014)
A Commission Regulation updating Annex XIV of the REACH Regulation has been published in the Official Journal. Annex XIV, also referred to as the 'Authorisation List' now contains 31 substances, with the new entries detailed below. If you use or supply any of the below substances, on their own, in mixtures or in the production of an article then you will require an authorisation to continue doing so beyond the 'sunset date' given.
|Substance||EC Number||CAS number||Property||Latest application date||Sunset date|
|Formaldehyde, oligomeric reaction products with aniline (technical MDA)||500-036-1||25214-70-4||Carcinogenic (1B)||22/02/2016||22/08/2017|
|Arsenic acid||231-901-9||7778-39-4||Carcinogenic (1A)||22/02/2016||22/08/2017|
|Bis(2-methoxyethyl) ether (diglyme)||203-924-4||111-96-6||Toxic for reproduction (1B)||22/02/2016||22/08/2017|
|1,2-dichloroethane (EDC)||203-458-1||107-06-2||Carcinogenic (1B)||22/05/2016||22/11/2017|
|2,2'-dichloro-4,4'-methylenedianiline (MOCA)||202-918-9||101-14-4||Carcinogenic (1B)||22/05/2016||22/11/2017|
|Dichromium tris(chromate)||246-356-2||24613-89-6||Carcinogenic (1B)||22/07/2017||22/01/2019|
|Strontium chromate||232-142-6||7789-06-2||Carcinogenic (1B)||22/07/2017||22/01/2019|
|Potassium hydroxyoctaoxodizincatedichromate||234-329-8||11103-86-9||Carcinogenic (1A)||22/07/2017||22/01/2019|
|Pentazinc chromate octahydroxide||256-418-0||49663-84-5||Carcinogenic (1A)||22/07/2017||22/01/2019|
Further information on the authorisation process is available to gold subscribers.
Consultation on alternatives: Trichloroethylene and diarsenic trioxide (14 August 2014)
ECHA has received applications for the authorisation of trichloroethylene (TCE) and diarsenic trioxide and has opened public consultations on feasible alternatives for the following uses:
|TCE:||Use of trichloroethylene as a solvent for the removal and recovery of resin from dyed cloth|
|Use of trichloroethylene as a solvent in a process to recover and purify resin from process water|
|Diarsenic trioxide:||Use of diarsenic trioxide as a processing aid for the removal of carbon dioxide from synthesis gas used in the production of ammonia|
Further information on these uses applied for, and commenting webforms, are available here. The consultation closes on 8 October 2014.
EC Inventory published on ECHA website (6 August 2014)
ECHA has published on its website a copy of the EC Inventory which it received from the JRC in 2008. The Inventory comprises:
- EINECS (European INventory of Existing Commercial chemical Substances). Substances which were commercially available in the EU between 1 January 1971 and 18 September 1981 are listed in EINECS with EC numbers in the form 2xx-xxx-x or 3xx-xxx-x;
- ELINCS (European LIst of Notified Chemical Substances). ELINCS substances are those which became commercially available after 18 September 1981 and before REACH entered into force and have EC numbers in the form 4xx-xxx-x;
- NLP (No-Longer Polymers). NLPs are substances which, due to a definition change in April 1992, are no longer considered to be polymers and thus are in scope of registration. NLPs that were commercially available between 18 September 1981 and 31 October 1993 were assigned EC numbers in the form 5xx-xxx-x. However; the list is not exhaustive and other NLPs exist.
Currently, the Inventory can be searched; additional functionalities, including the ability to download, are expected to follow.
Registry of SVHC intentions updated (30 July 2014)
The Registry of SVHC Intentions (SVHC RoI) has been updated and now shows ten substances for which Annex XV dossiers are expected to be submitted by Member States in August 2014.
Recent additions to the SVHC RoI include a multi-constituent dioctyltin substance for its CMR properties (Austria); four phthalates, although already Candidate Listed, for their endocrine disrupting properties (Denmark); and two nitrogen-containing heterocycles for their PBT properties (Germany). The list of substances which are expected to be proposed for Candidate Listing is shown below:
Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE) and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (MOTE)
Dibutyl phthalate; DBP
Benzyl butyl phthalate; BBP
Bis(2-ethylhexyl) phthalate; DEHP
Diisobutyl phthalate; DIBP
2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate; DOTE
The Candidate List of SVHCs is normally updated biannually, in June and December. Substances for which Annex XV dossiers are submitted in this round of proposals may therefore become Candidate Listed by the end of the year.
Last chance to register for ECHA Biocides Stakeholders' Day!
Registration for ECHA's second Biocides Stakeholders' Day closes on 31 July. To register for this free event, which will take place in Helsinki, Finland, on 24 September 2014, please complete the registration form. Attendees will also be able to book one-to-one sessions with ECHA staff to discuss particular aspects of the BPR.
The conference programme can be found here.
The event will be live web-streamed for those who want to follow proceedings online. Registration is not required; a link to the web-stream will be published on the ECHA website 24 hours prior to the event. A video recording of the web-stream will be published on the same page, together with the presentations, shortly after the event.
Correcting your registered substance identifier (07 July 2014)
ECHA has launched a new service allowing registrants to amend substance identifiers, for example EC numbers, in their dossiers. If the registered substance's identifier is incorrect, whether realised spontaneously by the registrant or as a result of an ECHA compliance check, registrants may apply - and pay - for ECHA to amend the information. Note that this service can only be used to refine the substance identity; it cannot be used to fulfil the registration obligations for a substance other than that which was originally intended to be registered.
To request the change, registrants should contact the ECHA Helpdesk. If the change concerns and affects a joint registration, the Lead Registrant will need to contact the Helpdesk on behalf of the co-registrants and submit a "joint submission plan".
The ECHA Management Board decision MB/D/29/2010 defines the scale of the charge levied. The minimum charge is 445 EUR for each registrant requiring the correction of a substance identifier. The deadline for payment is 30 days.
ECHA updates Candidate List (16 June 2014)
Today, ECHA has added four substances to the Candidate List of Substances of Very High Concern (SVHCs), taking the total to 155:
- Cadmium chloride
- 1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear
- Sodium peroxometaborate
- Sodium perborate; perboric acid, sodium salt
Companies supplying these substances alone, in mixtures or in articles may have legal obligations resulting from their inclusion in the Candidate List. To help our subscribers identify products likely to contain these newly identified SVHCs, we have updated our "common uses" document, found on the 'Member home page'. Log in or sign up today!
ECHA's "CLP 2015: Act Now!" campaign (5 June 2014)
ECHA has launched a series of new web pages to promote the CLP 2015 deadline. The new pages are designed to help suppliers of mixtures understand and meet their obligations under the CLP Regulation. They contain useful information on the CLP requirements, a support section on (re)classifying mixtures, multilingual terminology and related links, news and events.
As part of the CLP 2015 campaign, there will be a "Workshop on the safe use of chemicals by SMEs" on 16 September 2014 in Brussels. Further information is available here; registration details are expected to be published soon on the same web page.
Public consultation on alternatives to HBCDD (18 May 2015)
ECHA has received a joint application for the authorisation of hexabromocyclododecane (HBCDD) in two uses from 13 co-applicants and has consequently opened a public consultation on feasible alternatives:
- Formulation of flame retarded expanded polystyrene (EPS) to solid unexpanded pellets using HBCDD as the flame retardant additive (for onward use in building applications)
- Manufacture of flame retarded expanded polystyrene (EPS) articles for use in building applications.
Further information on these uses applied for, and commenting webforms, are available here. The consultation closes on 9 July 2014.
Amendments to the Biocidal Products Regulation (25 April 2014)
Amendments to the BPR entered into force today; key aspects include:
- The removal of the requirement for all products in a biocidal product family to have the same classification;
- The addition of STOT SE 1 and STOT RE 1 to the hazard classes for which products will not be approved for use by the public;
- Member States to grant product authorisations within three years of date of approval of active substance, rather than two;
- Six-month phase-out period introduced for treated articles containing active substances not added to the review programme by 1 September 2016;
- The potential inclusion of 'product suppliers' in addition to 'substance suppliers' on the list established under Article 95.
The amending Regulation, EU (No) 334/2014, may be found here.
Improvements to software used for REACH, CLP and BPR submissions (16 April 2014)
ECHA have announced updates to the submission software REACH-IT and R4BP, as well the launch of a new version of IUCLID.
The new version of REACH-IT (2.7) aims to improve the way in which companies receive communications from ECHA. Upon your next login to the system, you will be required to accept the new terms and conditions as well as verifying your email address. The new terms state that messages will be considered received from the point at which they are either: opened by anyone within the company; or, if unopened, 7 days after they are sent. Where the message relates to decisions or requests for information, the timelines set in the Regulation will begin from this date. The new version of REACH-IT can also be used to submit applications for authorisation.
Please note that Internet Explorer 11 will not allow access to REACH-IT as standard. Options are to use an alternative browser (e.g. Mozilla Firefox or Google Chrome), or to add europa.eu to the 'Compatibility View' in Tools, Compatibility View settings. (To access this menu option you may need to click the ALT key to bring up the menu bar in IE11.)
R4BP 3.1, which is used for making submissions under the Biocidal Products Regulation, has been changed to improve the submission process and allow greater efficiency in managing tasks.
In addition to these improvements, a new version of IUCLID has been launched to incorporate inclusions to the classification and labelling section due to the fourth revision of the GHS. For further information on the changes, and the text of the new terms and conditions for REACH-IT, click here.
Focus on substance identity in REACH registrations (9 April 2014)
Following an IT-based screening exercise, ECHA have sent 1,350 letters to registrants of 309 substances for which inconsistencies were found in the dossiers. The inconsistencies relate to required information on substance identity, and are detailed in the individual letters along with instructions on how to address them. Registrants are encouraged to proactively update their dossiers within three months of receipt of the letter before ECHA initiate any follow-up actions such as a compliance check.
Presentations from the 30 April ECHA webinar addressing the substance identity issues covered in the screening campaign are available here.
New list of CoRAP substances published (25 March 2014)
ECHA has published on its website a list of the 120 substances to be evaluated under the Community Rolling Action Plan (CoRAP) between 2014 and 2016. The list, which includes 53 new substances as well as 67 which have been carried over from last year, details the Member State which will carry out the evaluation.
Registrants of substances listed are advised to ensure their dossiers are up-to-date, and to interact with the evaluating Member State Competent Authority (eMSCA) as early as possible. To this end, the European Commission has agreed, along with ECHA and the Member States, a series of recommendations for coordinating their actions which ECHA has published on its website. In the paper, eMSCAs are encouraged to contact registrants of first-year CoRAP substances soon after the publication of the updated list. In addition, where the joint registration contains many members, eMSCAs should contact the Lead Registrant in the first instance. The recommendations also encourage registrants to 'speak with one voice' by appointing a Registrants Contact Point: a representative to coordinate communications and send consolidated comments on draft decisions.
For further information, click here.
Risk Assessment Committee vote on reclassification of bisphenol A (21 March 2014)
The Risk Assessment Committee (RAC) within ECHA has voted unanimously in agreement with the reclassification of bisphenol A from a category 2 reproductive toxicant to a category 1B reproductive toxicant. Bisphenol A is a monomer used in the manufacture of epoxy resins and polycarbonate plastics, and such a reclassification would, if agreed by the Commission, lead to a restriction on its incorporation into consumer products. The reclassification would also mean that bisphenol A could be included on the candidate list of SVHCs, meaning its potential eventual inclusion on Annex XIV (the 'Authorisation List').
The opinion was one of 16 given by the RAC at their recent meeting, with the other substances on which opinions were given listed below:
- Boric acid
- Disodiumoctaborate tetrahydrate
- Disodiumoctaborate anhydrate
- Lithium sodium 3-amino-10-(4-(10-amino-6,13-dichloro-4,11-disulfonatobenzo[5,6][1,4]oxazino[2,3-b]phenoxazine-3-ylamino)-6-[methyl(2-sulfonato-ethyl)amino]-1,3,5-traizin-2-ylamino)-6,13-dichlorobenzo[5,6][1,4]oxazino[2,3-b]phenoxazine-4,11-disulfonate (Direct Blue FC 57087)
- Hydroxyisohexyl 3-cyclohexene carboxaldehyde (INCI); reaction mass of 4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 3-(4-hydroxy-5-methylpentyl)cyclohex-3-ene-1-carbaldehyde; 4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde; 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde (HICC)
- Polyhexamethylene biguanide hydrochloride (PHMB)
For information on all of the decisions, click here.
Update to registered substances database (20 March 2014)
ECHA has updated the Registered substances disseminated dossier database with information from 634 new dossiers. At the same time, they have added additional details to those dossiers already disseminated to indicate the data on which dossiers were first submitted and last modified, and to show those substances for which the registrant has ceased manufacture/import.
Click here to search the database and view the detail of registrations.
New "Biocides" service launched (March 2014)
We have been answering our subscribers' Biocides-related questions for some time, but we have now formally added this as part of our service. As well as responding to questions relating to the Biocidal Products Regulation (BPR) through our Helpdesk we have added a new section to our website which provides background information and technical guidance on the regulation and the compliance issues companies face. Our public website has some introductory-level information; there is some expanded information available to our Silver (free) subscribers and a more comprehensive set of resources for our Gold subscribers. You can find out more information here - Biocides, or if you are already a subscriber log in to your account and navigate to the same area of the website to see the resources available to you.
ECHA updates C&L Inventory (04 March 2014)
ECHA has released a new update to the Classification and Labelling Inventory. The changes improve the information given on the summary C&L page and enhances user-friendliness and readability of the database. Highlighted changes include:
- Publicly available IUPAC names and the notified physical form in the "Additional Notified Information" column;
- Additional CAS numbers, for example for differently hydrated forms of the substance reported under the section "General Information";
- Impurity flags for notified substances where a notifier has indicated that an additive or impurity impacts the notified classification;
- Information on affected organs or specific effects and exposure routes as notified now displayed in the classification and labelling columns.
Users can now also export up to 9,999 search results for a substance of interest.
Little activity seen on Classification and Labelling Platform (14 February 2014)
Under Article 41 of CLP, companies are obliged to make every effort to come to an agreed classification and labelling entry if more than one has been submitted to the C&L Inventory for a given substance. To help facilitate such negotiations, ECHA launched its Classification and Labelling Platform in January 2013. This simple web-based discussion forum, accessible to REACH registrants and CLP notifiers alike, was developed to help companies discuss and agree on an appropriate classification for the substance.
Although ECHA has no publishable statistics, the Agency has confirmed that the Classification and Labelling Platform has seen little activity in the past 13 months. To quote the ECHA Infomation Desk, "only a small number of substances are actively discussed. This means that little progress with convergence of C&L entries has been achieved so far. To change the situation, the Commission has initiated actions with the Member States to further look into possibilities to facilitate agreement between companies".
Five substances recommended for Authorisation (11 February 2014)
ECHA has made a recommendation to the European Commission for a fifth batch of substances on the Candidate List to be included in Annex XIV to REACH, the Authorisation List. One of the five substances recommended, 4-tert-octylphenol ethoxylates, has effects on the environment due to its degradation to a substance with endocrine disrupting properties. The other four of substances recommended have human health hazard properties, being classified as carcinogenic, toxic for reproduction or respiratory sensitisers.
The five substances are:
- N,N-dimethylformamide (DMF): EC number 200-679-5
- Diazene-1,2-dicarboxamide (ADCA): EC number 204-650-8
- Aluminosilicate Refractory Ceramic Fibres (Al-RCF)
- Zirconia Aluminosilicate Refractory Ceramic Fibres (Zr-RCF)
- 4-tert-Octylphenol ethoxylates (4-tert-OPnEO)
Non-compliance found in 69% of evaluated dossiers (15 January 2014)
By the end of 2013, ECHA had completed compliance checks on 1,130 (5.7%) of the 19,772 registration dossiers submitted for the 2010 deadline. Of the evaluated dossiers, 69% were found to be non-compliant, resulting in draft decisions being sent to the registrants. The most common shortcomings were deficiencies in the information on substance identification and insufficient justification for missing information in the dossier or the Chemical Safety Report.
In this first wave of dossier evaluation, ECHA used both random selection and concern-based screening methods to identify dossiers, either for overall or targeted compliance checks. In an overall compliance check, ECHA looks to verify that the information necessary for safe use of the substance is present in the registration dossier. For the targeted checks, the focus is on specific parts of the dossier. A targeted check can also be escalated to an overall check if significant non-compliance which requires further assessment is identified.
More information on dossiers’ shortcomings can be found in the ECHA evaluation reports and in the public versions of the decisions. Existing and potential registrants alike are advised to make use of these sources of information to improve proactively their dossiers.
ECHA's scientific committees provide opinion on first application for Authorisation (3 January 2014)
The Risk Assessment Committee (RAC) and Socio-Economic Committee (SEAC) within ECHA have adopted their final opinions on an application for Authorisation made by Rolls-Royce plc.
Substances listed in Annex XIV of the REACH regulation are subject to Authorisation. That is, to continue using, or supplying for use, a substance listed in this Annex after the ‘sunset date’ therein specified, an Authorisation must be obtained. For an Authorisation to be granted, the applicant must demonstrate that the risk associated with their applied for use(s) of the substance is adequately controlled, or that there are no suitable alternatives available and that the socio-economic benefits of using the substance outweigh the risks.
The application submitted by Rolls-Royce plc., the details of which were subject to public consultation in the Autumn, is for the use of Bis(2-ethylhexyl) phthalate (DEHP) in a formulation used during the bonding and manufacture of aero engine fan blades. Based upon the risks posed by this use, the RAC and SEAC conclude that adequate control has been demonstrated and have proposed the Authorisation be subject to review in seven years.
The European Commission have three months following receipt of the committees' opinions to prepare a draft decision as to whether or not the Authorisation should be granted. This decision will then be adopted under the regulatory committee procedure.
To view the adopted opinion, click here.
For news items from 2012 and earlier, please see our News archive.
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