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.
Candidate List updated with seven new substances of very high concern (16 December 2013)
Today, ECHA has added seven substances to the Candidate List for Authorisation, taking the total number of SVHCs to 151:
- Cadmium sulphide;
- C.I. Direct Black 38;
- C.I. Direct Red 28;
- Dihexyl phthalate;
- Trixylyl phosphate;
- Lead di(acetate).
Cadmium sulphide was added to the Candidate List as it is carcinogenic and also as it was identified as being of an equivalent concern based on probable serious effects to human health, specifically due to the effects on kidney and bone. C.I. Direct Red 28 and C.I. Direct Black 38 were also identified as carcinogens, and the other four substances were identified as being toxic for reproduction.
REACHReady's summary of the "common uses of the Candidate List substances" has been updated and is available online to all our subscribers.
2020 SVHC roadmap implementation plan published (11 December 2013)
Earlier this year, the European Commission made a political commitment to include 'all relevant known' SVHC in the Candidate List by 2020. ECHA has now published an implementation plan to this goal, also dedicating a new webpage to the '2020 roadmap'.
Although a significant number of substances are thought to meet the criteria of SVHC, such substances can only be included on the 'candidate list' following the submission by a Member State of an Annex XV dossier. The 2020 SVHC roadmap aims at coordinating Member States' activities on substance selection with clear deliverables and responsibilities, whilst ensuring predictability and transparency of the process. It describes how to examine the substances that may belong to the above categories, by giving priority to those registered under REACH that are used not only as chemical intermediates. A list of the substances to be assessed will be made publicly available in the future.
More information on the topic, as well as the implementation plan itself, are available on the ECHA website.
Draft update to CoRAP for 2014-16 (4 November 2013)
ECHA has published a proposal to update the Community Rolling Action Plan (CoRAP) for 2014-16. The draft plan introduces 125 substances that are proposed for Member States (MS) to review under the substance evaluation process. It contains 56 substances newly allocated to the MS and 69 substances already included in the CoRAP update published on 20 March 2013. The substances are tentatively divided for evaluation in years 2014, 2015 and 2016.
According to ECHA, the Member State Committee will prepare an opinion on the draft CoRAP update in February 2014. On the basis of the Committee’s opinion, ECHA will adopt the final CoRAP update for 2014-2016 by the end of March 2014.
Early communication between registrants and the relevant evaluating Member State is recommended if your substance is listed on CoRAP.
ECHA publishes comments on first application for Authorisation (18 October 2013)
Following a public consultation, which closed on 9 October, ECHA has this week published the comments received on the first application for an Authorisation under Title VII of REACH. The application, submitted by Rolls-Royce Plc., is for the use of Bis(2-ethylhexyl) phthalate (DEHP) in a formulation used during the bonding and manufacture of aero engine fan blades. Of the comments received, three were from non-governmental organisations (NGOs) who all noted the failure of the applicant to include a substitution plan in their application, despite a viable alternative being identified through the analysis of alternatives. One also commented on failings in the chemical safety report to define adequately the tasks undertaken and the control measures used; as well as the use of a monitoring survey unsuitable for the task described. The final two comments were both received from Kooperationsstelle, a company dealing with occupational safety, health and protection in Germany, and focussed on alternatives not considered by the applicant.
As this is the first application for Authorisation to be published on the ECHA website, one NGO took the opportunity to provide comment on the consultation process as well as the application itself. Comments centred around a lack of clarity in the nature of the confidential information to have been removed from the publicly available documents, and a focus on the substance rather than process in the details of use, meaning comments on non-chemical alternatives were unlikely to be received.
The Risk Assessment Committee (RAC) and Socio-Economic Analysis Committee (SEAC) within ECHA have a further 8 months from the close of the public consultation to provide comments on the application, taking into account the information received during the public consultation.
To view the original application and the comments provided, click here.
ECHA's report on substitution costs (25 September 2013)
In 2011, ECHA commissioned studies to estimate the substitution costs of six substances of concern. A report now published presents the results of the research, with the aim of providing support for the assessment of abatement costs. ECHA says the learning points will be useful to Member States working on restriction dossiers and to companies working on authorisation applications.
The case studies reported are:
- Nonylphenol and nonylphenol ethoxylates in textiles;
- Four phthalates (DEHP, BBP, DBP and DIBP);
- 1,4 - Dichlorobenzene in toilet blocks and in air fresheners;
- Lead in shot;
- Hexabromocyclododecane (HBCDD),
A copy of the report is available here.
IUCLID 5.5.1 released (12 September 2013)
The first update to IUCLID 5.5 has been published on the IUCLID website. Although not a compulsory download, a significant advantage of IUCLID 5.5.1 is that it allows the use of a dossier template for Chesar. This functionality allows the selection of the IUCLID information needed for the chemical safety assessment to be imported into Chesar.
IUCLID 5.5.1 includes a number of other improvements and new features. For example, error messages received on importing "light" dossiers have been improved, indicating the details of the missing attachments or information. A number of modifications and corrections have been made to the section tree labels, and the section numbering for the BPR has been changed. On the distributed version, using the user preferences, the user is now able to open several clients connected to the same server, from the same workstation.
In addition, the list of supported software has been updated. Windows Vista, Windows Server 2003, PostgreSQL 8.4, Linux CentOS, Oracle 10g and Apache Tomcat 5.5 are no longer supported; newly supported are Windows 8, Windows Server 2012, and PostgreSQL 9.1 and 9.2.
Public consultation opens on first application for Authorisation (14 August 2013)
Following the first application for an Authorisation under the REACH Regulation, ECHA is inviting interested parties to provide comment. The application, made by Rolls-Royce, is for the use of Bis(2-ethylhexyl) phthalate (DEHP) in a formulation used during the bonding and manufacture of aero engine fan blades. The eight week public consultation closes on 9 October 2013, and interested parties are invited to comment on any alternative substances or technologies to the use applied for as well as the risks, technical feasibility and potential costs of these. In order to provide comment yourself, or view comments submitted by other individuals, the ECHA website has created a page dealing with applications for authorisation.
If you are interested in the authorisation process, sign up as a gold subscriber for access to exclusive content including guidance documents on applying for authorisation, as well as access to the REACHReady Helpdesk.
ECHA publish aims towards improving safety data sheets (17 July 2013)
ECHA has today set out a long-term action plan aimed towards enhancing the quality of information communicated through the supplier chain under REACH. Focussing on chemical safety reports and extended safety data sheets, the roadmap has been developed by ECHA in partnership with various industry associations and member states.
Details of the intended actions have been published on the ECHA website, along with information on how you can contribute.
ECHA updates candidate list of SVHCs (20 June 2013)
ECHA today announced the addition of six new substances to the Candidate List of substances of very high concern (SVHCs), taking the total to one hundred and forty four. ECHA's News Alert confirms that all six of the substances were added following the unanimous agreement of the Member State Committee; although a decision on a further four substances expected to be added to the list at this time has not been made.
The six substances added are: cadmium and cadmium oxide (due to carcinogenic properties); ammonium pentadecafluorooctanoate (APFO and pentadecafluorooctanoic acid (PFOA) (due to reproductive toxicity and meeting PBT criteria); dipentyl phthalate (DPP) (due to reproductive toxicity); and 4-nonylphenol, branched and linear, ethoxylated (due to equivalent levels of concern under article 57 f).
Companies may have legal obligations resulting from the inclusion of these substances in the Candidate List which may apply to the listed substances on their own, in mixtures or in articles. Producers and importers of articles have until 20 December 2013 to notify ECHA where the SVHC is present in those articles above 0.1% by weight and totals 1 tonne or more per year, unless the substance is already registered for that use or exposure can be excluded.
REACHReady Helpdesk remains busy in the final stages of the second REACH registration deadline
At the close of the second REACH deadline REACHReady has successfully answered a steady flow of registration related questions from its gold subscribers. However, symptomatic of the relatively low number of 2013 registrations in comparison to the number predicted, registration remains only one of the key topics of concern to REACHReady’s subscribers.
For more information please see our Press Release.
Final advice for companies registering by 31 May 2013
ECHA has given some final advice to registrants ahead of the 31 May 2013 deadline. Lead Registrants are encouraged to submit their dossier as soon as possible to allow member registrants to submit their own dossiers in time. The LR's dossier must pass the 'business rules' before members submit their dossier. Member registrants must also confirm their membership of the joint submission using the token provided by the LR before they submit their member dossier.
The advice also encourages companies who are still having difficulties in meeting their registration obligations to contact the ECHA Helpdesk who will provide a response to registrants having an 'exceptional' situation.
The guidance includes key advice for successful dossier submission, such as ensuring company information is correct, verifying company size, taking care that substance identity is clear, and use of IUCLID tools to ensure dossier quality and completeness.
Eight substances added to the Authorisation List (19 April 2013)
Annex XIV of REACH has been amended by Regulation (EU) No 348/2013, with a further eight substances being subject to Authorisation:
- Chromium trioxide
- Sodium dichromate
- Potassium dichromate
- Ammonium dichromate
- Potassium chromate
- Sodium chromate
- Acids generated from chromium trioxide and their oligomers. Group containing:
- Chromic acid and,
- Dichromic acid
- Oligomers of chromic acid
The sunset date, after which the substance cannot be used or manufactured in the EEA unless exemption applies or without authorisation for a specific use, is 21 April 2016 for trichloroethylene and 21 September 2017 for the chromium compounds. Companies that wish to use an Annex XIV substance after the sunset date need to apply for authorisation (unless their use is exempt); applicants who submit an application before the "latest application date" may continue to use the substance after the sunset date while they wait for a decision from the European Commission.
The Authorisation List now contains 22 substances.
ECHA offers DCG support in 'exceptional' cases for 2013 registration
The Directors' Contact Group (DCG) was set up in January 2010, with objectives to monitor the overall preparedness of companies for registration and to resolve priority issues of concern relevant to registration. After the first registration deadline, the work of the DCG was framed by a new mandate with emphasis on monitoring progress towards the 2013 deadline.
Potential registrants concerned they are in an exceptional situation preventing their substance registration by 31 May 2013 are advised to contact ECHA before they submit their dossier. There are eight scenarios from the "Summary Paper on 28 issues and solutions" for which potential registrants may contact ECHA:
- Completeness of dossier
- Difficulties for importers to obtain data on substances in mixtures, for example determining to which substance an impurity belongs (Issue 10.2)
- Results of testing required in Annexes VII and VIII not available by the registration deadline despite the tests being ordered in a timely manner (Issue 10.3)
- Legal entity change
- Company split in which a resultant legal entity(s) does not have a pre-registration and is not eligible for late pre-registration (Issue 15.1)
- Transfer of assets where legitimate late pre-registration is not possible for the company without a pre-registration (Issue 15.2)
- Transfer of production from one entity to another where legitimate late pre-registration is not possible for the company without a pre-registration (Issue 15.3)
- Dependency on Lead Registrant
- Lead Registrant has submitted a registration but fails to complete the dossier within the Technical Completeness Check deadline (Issue 20.1)
- Lead Registrant fails to submit his registration dossier before the registration deadline (Issue 20.2)
- SIEF without an EU manufacturer
- If a substance is manufactured only outside EU, it is often difficult for an Only Representative or importer to take up the Lead Registrant role. Should a Downstream User take up the role of Importer if their supplier fails to register late pre-registration may not be possible (Issue 21).
Companies are requested to provide detailed justification of their situation and an explanation of the measures taken to comply with REACH to benefit from the ECHA support.
Please note: if you are not required to register your substance by 31 May 2013 then DCG issues do not apply to you.
Follow the 2013 registration progress online (22 March 2013)
In a new initiative, ECHA is publishing specific information on registration progress towards the 2013 deadline. This information is updated weekly and is available on the REACH 2013 web page.
The new information relates to the number of substances registered for the deadline, and provides a breakdown by type, role in the joint submission, company size and the role of the registrant (manufacturer, importer, or OR). Additionally, the number of registration dossiers submitted in each of the Member States and the number of dossiers being processed is presented.
The REACH 2013 web page will continue to provide an overview of the substances intended to be registered by 31 May, together with detailed lists on registration intentions and lead registrant nominations. The web page also provides support on IT tools for the registration process and tips and guidance for their role in the joint submission.
ECHA anticipates the registration of approximately 4000 substances by the 31 May deadline. Of these, 900 were already registered for the 2010 deadline and 3100 are additional substances for the 2013 deadline.
Ten potential SVHCs added to the Registry of Intentions for inclusion on the Candidate List (4 March 2013)
Member States Competent Authorities (MSCAs) from Germany, Poland and Sweden have recommended 10 substances for addition to the REACH candidate list. For the first time this includes substances based on their specific target organ toxicity after repeated exposure. Four of the substances are phenolic benzotriazoles and other proposals are for ammonium pentadecafluorootanoate (APFO) and pentadecafluorooctanoic acid (PFOA), 4-nonlyphenol, branched and linear, ethoxylated, cadmium and cadmium oxide and di-n-pentyl phthalate. The consultation will be open for 45 days and will end on 18 April 2013.
Annual CoRAP update published (20 March 2013)
The Community rolling action plan (CoRAP) for 2013-2015 covers 115 substances that are suspected of posing risk to human health or the environment. Of these substances, 62 are newly allocated and 53 come from the first CoRAP adopted in 2012. The updated CoRAP list has been prepared in cooperation with the Member States, taking into account the agreed risk-based criteria for the selection of substances.
From the publication of the CoRAP update, the respective Member States have one year to evaluate substances specified for 2013 and, where justified, to prepare a draft decision requesting the registrants to submit further information to clarify any possible risk. The decision will be taken by ECHA after consultation of the Member State Competent Authorities and the MSC, or by the European Commission if there is no unanimity at the MSC. Registrants are encouraged to communicate with Member States in order to clarify any concerns related to the substances, in particular those under evaluation in 2013.
REACH Review published (5 February 2013)
The European Commission has published the REACH Review which reports on the regulation's effect and the recommendations to reinforce ECHA's long term strategic objectives. The European Commission notes in its REACH review report that the REACH Regulation functions well and delivers on all the objectives as demonstrated by the valuable studies it summarised in the Staff Working Document. It does state that within the current framework, however, there is a need to reduce the impact of REACH on SMEs. The annex to the general report sets out measures that will contribute to this goal. Some key findings and recommendations are:
- The report makes recommendations to improve REACH implementation. These include improving the quality of registration dossiers, enhancing the use of safety data sheets as a central risk management tool, and addressing issues related to cost sharing within Substance Information Exchange Forums (SIEFs).
- The report recommends reducing the financial and administrative burden on SMEs in order to ensure the proportionality of legislation and to assist them to fulfil all their REACH obligations.
- There are no major overlaps with other EU legislation.
- Considerable efforts to develop alternative methods to animal testing have been made and will continue: since 2007, the Commission has made available € 330 million to fund research in this area.
- Enforcement could be improved. As this is the responsibility of the Member States, the report recommends that Member States reinforce coordination amongst them.
- Although the report identifies a need for some adjustments to the legislation, the Commission wants to ensure legislative stability and predictability for European businesses. No changes to REACH's main terms are proposed at present.
As one of the "next steps" The Commission will also follow up on the registration requirements for substances in tonnages between 1 and 10 tonnes and the impact of REACH on innovation and report back by January 2015.
ECHA recommends 10 SVHCs for authorisation (17 January 2013)
ECHA has recommended that ten substances of very high concern are included to the authorisation list. The substances are classified as carcinogenic or toxic to reproduction and are used in applications where there is potential for worker exposure. They have been prioritised based on their hazard properties, volumes used, and use related potential for exposure to humans. In its recommendation the Agency took into account the comments received during the public consultation last summer and a recent opinion of the Member State Committee, which supports ECHA's recommendation. For each substance recommended for inclusion in Annex XIV, a proposed sunset date is suggested. After this deadline companies will only be able to use it within the EU if an authorisation has been granted.
The final decision on the inclusion of the substances in Annex XIV and their sunset dates will be taken by the European Commission according to Comitology procedure.
For news items from 2012 and earlier, please see our News archive.
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