ECHA has added two new chemicals to the Candidate List.
One is toxic for reproduction and the other has very persistent and very bioaccumulative hazardous properties. They are used, for example, in inks and toners and in the production of plastic products.
Entries added to the Candidate List on 14 June 2023:
#
Substance name
EC number
CAS number
Reason for inclusion
Examples of use(s)
1
Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide
278-355-8
75980-60-8
Toxic for reproduction (Article 57c)
Inks and toners, coating products, photo-chemicals, polymers, adhesives and sealants and fillers, putties, plasters, modelling clay.
2
Bis(4-chlorophenyl) sulphone
201-247-9
80-07-9
vPvB
(Article 57 e)
Manufacture of chemicals, plastic products and rubber products.
The Candidate List now has 235 entries – some are groups of chemicals so the overall number of impacted chemicals is higher.
These substances may be placed on the Authorisation List in the future.
If a substance is on that list, its use will be prohibited. Companies must apply for authorization from the European Commission to continue its use.
Consequences of the Candidate List
Under REACH, companies must fulfill legal obligations. These obligations apply when their substance is included in. the Candidate List, either on its own, in mixtures, or in articles.
Suppliers of articles containing a substance listed in the Candidate List above a concentration of 0.1% (w/w) are obligated to furnish their customers and consumers with information necessary for safe usage. Consumers have the right to ask suppliers whether the products they buy contain substances of very high concern.
Importers and producers of articles must notify ECHA if their article contains a substance from the Candidate List within six months of its inclusion (14 June 2023). Suppliers of substances listed must provide safety data sheets to their customers, whether supplied alone or in mixtures.
Under the Waste Framework Directive, companies also have to notify ECHA if the articles they produce contain substances of very high concern in a concentration above 0.1 % (weight by weight). This notification is published in ECHA’s database of substances of concern in products (SCIP).
The European Chemicals Agency (ECHA) has recommended eight substances, including lead, for addition to the REACH Authorization List to protect workers and the environment.
Helsinki, 12 April 2023 – ECHA’s 11th recommendation includes the following substances:
• Ethylenediamine;
• 2-(4-tertbutylbenzyl)propionaldehyde and its individual stereoisomers;
• Lead;
• Glutaral;
• 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one;
• 2-benzyl-2- dimethylamino-4’-morpholinobutyrophenone;
• Diisohexyl phthalate; and
• Orthoboric acid, sodium salt.
ECHA has prioritized these substances from the Candidate List of substances of very high concern for this recommendation as they are of the highest priority, following the agreed approach of 2014. If substances are added to the list, companies will need to apply for authorization to continue using them.
The authorisation process aims to ensure proper control of risks for human health and the environment, and to enhance substitution of substances of very high concern when technically and economically viable alternatives are available.
The European Commission will decide which substances are included in the Authorisation List and what conditions apply for each substance.
Helsinki, 17 January 2023 – ECHA has added nine chemicals to the Candidate List because of their hazardous properties. They are used for example in flame retardants, paints and coatings, inks and toners, coating products, plasticisers and in the manufacture of pulp and paper.
Entries added to the Candidate List on 17 January 2023:
Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof
–
–
Isobutyl 4-hydroxybenzoate
224-208-8
4247-02-3
Melamine
203-615-4
108-78-1
Perfluoroheptanoic acid and its salts
–
–
reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine
473-390-7
–
ECHA’s Member State Committee confirmed the addition of these substances to the Candidate List. The Candidate List now has 233 entries – some are groups of chemicals so the overall number of impacted chemicals is higher.
These substances may be placed on the Authorisation List in the future. If a substance is on that list, its use will be prohibited unless companies apply for authorisation and the European Commission authorises them to continue its use.
Consequences of the Candidate List
Under REACH, companies have legal obligations when their substance is included – either on its own, in mixtures or in articles – in the Candidate List.
Suppliers of articles containing a Candidate List substance above a concentration of 0.1 % (weight by weight) have to give their customers and consumers information to be able to use them safely. Consumers have the right to ask suppliers whether the products they buy contain substances of very high concern.
Importers and producers of articles will have to notify ECHA if their article contains a Candidate List substance within six months from the date it has been included in the list (17 January 2023). Suppliers of substances on the Candidate List, supplied either on their own or in mixtures, have to provide their customers with a safety data sheet.
Under the Waste Framework Directive, companies also have to notify ECHA if the articles they produce contain substances of very high concern in a concentration above 0.1 % (weight by weight). This notification is published in ECHA’s database of substances of concern in products (SCIP).
As a high number of authorisation applications are expected for hexavalent chromium (Cr(VI)) uses in the coming years, the way of information sessions for these uses will be changed. In the future, will organised for groups of several applicants.
The first group session will take place on 15 February 2023, and more will be organised after that based on need. Future dates will be announced in the bulletin.
Chromium trioxide (EC No. 215-607-8; CAS No. 1333-82-0) is widely used in plating and surface treatment.
Notifications from 1 026 sites across Europe submitted by May 2021. confirm that chromium trioxide is still widely used in functional or hard chrome plating and surface treatment. The annual usage is estimated to be 7 000 tonnes. The substance of very high concern was placed on the Authorisation List in 2013 and its use has needed a specific authorisation in the EU since 2017.
By notifying the uses to ECHA, companies confirm that they follow the conditions for use set in the authorisation decisions granted to their suppliers. As part of the conditions, they must inform ECHA by the end of 2021 how their workers are exposed to chromium trioxide. This information will help companies to protect their workers even better by minimising their exposure to the carcinogen.
In December 2020 European Commission published 2 decisions granting authorisation to use the chemical until September 2024.
Enforcement authorities can now carry out inspections as necessary.
There are 2 principal duties for companies using chromium trioxide:
Apply for REACH authorisation in time;
Comply with the conditions comunicated by suppliers through extended safety data sheets.
The chromium trioxide applications for REACH authorisation by companies is now accelerating.
Joint authorisation originally applied by CETAC consortium (and others) will be ineffective after September 2024.
Ekotox Centers offer complex services to prepare all necessary documents on behalf of the customers. To stay on the market there is need for immediate action!
On the same time there is a duty to comply with the safety measures and operational conditions – requirements defined for downstream users by eSDS. To be sure that all is in compliance Ekotox Centers provide support to manage „Internal Dossiers for REACH Authorisation Compliance“ (IDRAC).
Five substances added to REACH Authorisation List. The Authorisation List now contains 59 entries.
The five substances are:
Tetraethyllead (TEL) (EC 201-075-4, CAS 78-00-2);
4,4′-bis(dimethylamino)-4”-(methylamino)trityl alcohol [with ≥ 0.1% w/w of Michler’s ketone (EC 202-027-5) or Michler’s base (EC 202-959-2)] (EC 209-218-2, CAS 561-41-1);
Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) [with ≥ 0,1% w/w 4-heptylphenol, branched and linear (4-HPbl)] (EC -, CAS -);
2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE) (EC 239-622-4, CAS 15571-58-1); and
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) (EC -, CAS -).
The amendment of the Authorisation List (Annex XIV to REACH) was published on 11 April in the EU’s Official Journal.
Companies that want to continue using these substances after the agreed sunset dates will need to apply for authorisation.
This report takes a detailed look at the impacts of REACH authorisation on trichloroethylene (TCE) from its inclusion on the Candidate List in 2010 until January 2022.
The need to obtain authorisation significantly reduced the use of TCE. The annual use of TCE in the EU has dropped more than 95 % in the past 12 years.
ECHA has published an updated format for companies to use when applying for authorisation to use substances of very high concern (SVHCs).
The new format combines the analysis of alternatives, the socio-economic analysis and, when relevant, a substitution plan into a single document.
The new format is easier for applicants to fill in. The possibility to submit separate documents has been removed making the application process more efficient and the documents more coherent. The instructions on confidentiality have also been updated.
At the same time, the opinion format for the Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) has been revised to take the General Court’s judgments in two authorisation cases into account.
The judgments concerned situations where suitable alternatives are available in general and the applicants would need to submit a substitution plan. As requested by the European Commission, the opinion format also includes “a conclusion on whether or not the applicant has shown that the benefits for society from using the substance outweigh the risk to human health or the environment”.
Applicants should start using these formats immediately.
However, applications may be submitted in the old format until the end of 2021 if applicants have already finalised or are close to finalising the content of their application.
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