Following an amendment to the EU’s Prior Informed Consent (PIC) Regulation. EU exporters are now obligated to notify their intentions to export 35 additional hazardous chemicals. The new rules start applying on 1 November 2023.
In addition to the export notification, most of these chemicals will also require an explicit consent from the importing country before exports can take place. Furthermore, four chemicals that were previously subject only to an export notification, will now also require an explicit consent.
Commission Delegated Regulation (EU) 2023/1656 of 16 June 2023 amending Regulation (EU) No 649/2012 of the European Parliament and of the Council. This amendment concerns the listing of pesticides and industrial chemicals.
ECHA: Main alternatives to harmful substances subject to REACH authorisation
Companies applying for an authorisation under REACH need to provide information on potential alternatives to the Annex XIV substance(s) they use. This information is presented in the Analysis of Alternatives (AoA) submitted as part of their authorisation application. The public version of the AoA is published on ECHA’s website.
The main information on these alternatives has been extracted from AoAs and is available in the Shortlisted Alternatives Table. The file contains data available as of 30 June 2023.
The restriction on formaldehyde and formaldehyde-releasing substances has been adopted by the Commission on July 14, 2023 and was published on July 17 in the OJEU: Regulation No. 2023/1464.
This new entry, n° 77 of annex XVII of REACH, aims to prohibit the placing on the market of articles containing formaldehyde or formaldehyde-releasing substances, for which the formaldehyde concentrations emitted exceed 0.062 mg/m3 for wood-based articles, furniture and 0.08 mg/m3 for other articles. A special provision is mentioned therein for the interior of road vehicles in which the concentration of formaldehyde emitted must not exceed 0.062 mg/m3.
Commission Regulation (EU) 2023/1464 of 14 July 2023 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards formaldehyde and formaldehyde releasers.
Regulations 2023/1434 and 2023/1435, which amend Annex VI to the CLP, were published in the Official Journal on 11 July. They come into force on 31 July 2023.
Regulation 2023/1435
The amendment revises the harmonised classifications of compounds of boron in Annex VI to CLP. Similarly, it updates the classifications of 2-ethylhexanoic acid (2-EHA) and its salts. Those New classifications will be applicable from 1 February 2025.
Regulation 2023/1434
creates new notes in connection with these entries:
Notes 11 and 12 relating to the additivity of the hazard for reproductive toxicity:
Note 11 specific to Borates,
Note 12 applicable to 2-EHA and likely to be attributed, in the future, to substances others ; it is worded so that it is not limited to the entry of 2-EHA,
They specify that the classification of mixtures as toxic for reproduction is necessary when the sum of the concentrations of the different substances in the mixture placed on the market is equal to or greater than 0.3%.
Note X (applicable to 2-EHA but likely to be assigned to others in the future).
It specifies that the classification is only based on the hazardous properties of the structural part common to substances. The substances covered by this note must therefore be self-classified to take into account the dangers associated with other structural elements.
COMMISSION DELEGATED REGULATION (EU) 2023/1434 of 25 April 2023 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures as regards the addition of notes to Part 1, section 1.1.3, of Annex VI
Commission Delegated Regulation (EU) 2023/1435 of 2 May 2023 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures as regards the modification of entries in Part 3 of Annex VI for 2-ethylhexanoic acid and its salts, boric acid, diboron trioxide, tetraboron disodium heptaoxide hydrate, disodium tetraborate anhydrous, orthoboric acid sodium salt, disodium tetraborate decahydrate, and disodium tetraborate pentahydrate
The European Chemicals Agency’s (ECHA) Enforcement Forum has announced two major projects to ensure compliance with regulations for products sold online. The first project, called REACH-EN-FORCE (REF)-13, will involve inspections in 2025 to check if products such as toys, household goods, and chemicals sold online meet REACH restrictions. Inspectors will also verify that mixtures are properly classified, labeled, and packaged according to the Classification, Labelling and Packaging (CLP) Regulation. Compliance with other regulations, such as the Persistent Organic Pollutants (POPs) Regulation and the Restriction of Hazardous Substances (RoHS) Directive, may also be assessed.
The REF-8 project revealed that a significant percentage of mixtures and articles sold online violated REACH restrictions, with 78% failing to meet the necessary conditions. The upcoming project will benefit from stricter rules for online sales, such as the Digital Services Act and General Product Safety Regulation, which are expected to enhance enforcement efforts.
The second project, known as the Biocidal Products Regulation (BPRS), will focus on the correct labeling of biocidal products. Inspectors will ensure that the information on product labels aligns with the authorized details included in the Summary of Product Characteristics. They may also assess the presence and quality of information in Safety Data Sheets for biocidal products.
Both the REF-13 and BPRS projects will be prepared in 2024, with inspections planned for 2025, and reports expected to be published in 2026. Additionally, during the meeting, new chairs and vice chairs were elected for the Forum and its biocides subgroup. Henrik Hedlund (SE) will serve as the Forum chair, while Katja vom Hofe (DE) and Maria Orphanou (CY) will be the vice chairs. Helmut de Vos (BE) was elected as the chair of the biocides subgroup, alongside Jenny Karlsson (SE) and Eugen Anwander (AT) as vice chairs.
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 compliance date for industrial use only mixtures, focusing on the second poison centre compliance date set for January 2024.
Industrial use only mixtures – the transitional period, information requirements, the. use of Unique Formula Identifier (UFI), and available tools and support for compliance.
Industrial Use Only Mixtures: These mixtures are exclusively used in industrial sites and are not accessible to consumer or professional users as a final product or in diluted form. For example, an automotive paint used only at an industrial site is an industrial use only mixture.
Transitional Period: Industrial use only mixtures already notified via national submission systems before the 2024. compliance date may benefit from a transitional period until January 1, 2025. However, any modifications made. to the mixture’s composition, product identifiers, classification, or toxicological information during this period require a harmonized format notification before market introduction.
Information Requirements: The harmonized information requirements include full chemical composition, toxicological information, product details, and the Unique Formula Identifier (UFI) as outlined in Annex VIII to the CLP Regulation.
Limited Submission for Industrial Use Mixtures: Industrial. use mixtures have the option of a “limited submission” where compositional information from the Safety Data Sheet can be used. However, a contact person providing complete compositional details in case of an incident must be included in the notification.
UFI in Notification and Labeling: Hazardous mixtures requiring notification must have a UFI in both the Poison Centre Notification (PCN) and on the product label. If a hazardous mixture is exclusively used at an industrial site, the UFI may be indicated only in Section 1.1 of the Safety Data Sheet. If the same mixture is available to consumer or professional users, the UFI is required on the label.
Main Use from EuPCS: The main intended use of a mixture is identified. by selecting the most relevant category from the European Product Categorization System (EuPCS). Secondary uses may also be included if applicable. For any difficulties in assigning a product category, industry associations or the helpdesk can provide recommendations or assistance in requesting a change to the EuPCS.
The upcoming compliance date of January 2024 for industrial use only mixtures necessitates adherence. to harmonized information requirements outlined in Annex VIII to the CLP Regulation. Companies must ensure compliance and utilize available tools and support to facilitate successful notification. The report emphasizes the distinction between industrial use only mixtures and industrial use mixtures, the transitional period, .the role of UFIs, and the need for accurate product categorization as per the EuPCS.
EU has published a Delegated Regulation amending CLP Regulation, which sets out new hazard classes and criteria for the classification, labelling and packaging of substances and mixtures.
It applies to all chemical substances and mixtures placed on the EU market under REACH. It also applies to active substances in biocidal products. and plant protection products, which are normally prioritised for harmonised classification in the EU.
ECHA provides advice on new hazard classes for substances and mixtures
Three new hazard classes for classifying, labelling and packaging (CLP) substances and mixtures enter into force on 20 April 2023. ECHA has published information on the application dates and related guidance.
The European Commission has updated the Classification, Labelling and Packaging Regulation with the following hazard classes:
endocrine disruptors (ED) for human health or the environment;
persistent, bioaccumulative and toxic (PBT); very persistent and very bioaccumulative (vPvB); and
persistent, mobile and toxic (PMT); very persistent and very mobile (vPvM).
Companies and Member State authorities can use current guidance on identifying endocrine disruptors and. on PBT (persistence, bioaccumulation, toxicity) assessment until the guidance on applying the CLP criteria has been updated. It is expected to be ready in 2024. and make their dossiers comply with the information requirements, where needed.
What are the obligations for companies following the entry into force of the Commission Delegated Regulation (EU) 2023/707 of 19 December 2022?
Once the Delegated Regulation 2023/707 enters into force (20 April 2023), manufacturers, importers, downstream users and distributors should consider the following tasks in order to comply with their duties. The exact order and timing will depend on the specific scenario of each operator: if they place on the market substances or mixtures; if they are members of a joint submission or not; if their substance or mixture is already placed on the market or not, etc. The list is not exhaustive but lists the main tasks triggered by the new legal text.
Review the classification and labelling of the substances and mixtures in their portfolio against the criteria of the new hazard classes. They should use all available information for self-classification.
Take note of the transitional periods for substances and mixtures that apply to them and make. sure they have fulfilled their duties at the latest by those dates. Transitional periods allow to comply earlier and avoid last-minute difficulties.
If they are part of a joint submission under REACH, initiate the discussion to agree on the classification and labelling of their substances. Update the registration dossier without undue delay, as outlined in the Implementing Regulation 2020/1435.
If they are part of a group of manufacturers/importers for the purpose of C&L notification, initiate the discussion to agree on the classification and labelling of their substances. Update the notification to the inventory accordingly.
Contact the other notifiers for the same substance to agree on the new classification and labelling. The leader of the joint submission, or the leader of the group of manufacturers/importers, if the operator is a member of either, can help in such communication.
Revise their labels, for both substances and mixtures.
Update, when relevant, any poison centre notification they have already made, with the new hazard information.
Consider whether a new poison centre notification is needed. Mixtures previously not classified for human health nor physical hazards may have to be classified for the new human health hazards from 1 May 2026.
Update their safety data sheets (SDS) with the new classification and labelling, and all relevant new information that is. needed to reflect the new hazards. They may need to compile an SDS for substances or mixtures which were previously not classified.
Prepare to compile and provide an SDS upon request if their mixtures are not classified but contain a substance in 0,1% or more of an endocrine disruptor Category 2 and is not intended for the general public.
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.
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