REACH REVISION 2024/2025
The REACH Regulation is currently under revision. The European competent authorities agreed on their plans to revise the regulation in the 48th CARACAL* Meeting held on 28-29 March 2023. Shortly after, the European Commission published an overview of the envisaged changes.
According to the tentative time frame, the Commission intends to put forward a detailed legislative proposal at the latest in the fourth quarter of 2023 and its final version, including the Annexes, in 2024-2025.
SCC REACH experts have been keeping track of latest developments and have prapared a summary of the most relevant changes you should be aware of. These include:
Obligation for regular REACH dossier updates
Irrespective of the intended changes in the REACH Regulation, all registrants have a clear obligation to keep their dossiers up to date on their own initiative and ‘with undue delay’ when their chemicals data, tonnage band or company information change, as stipulated in the Commission Implementing Regulation (EU) 2020/1435 of 9 October 2020.
We will keep you regularly updated on the current status of the REACH revision. If you need help or have a question, please do not hesitate to contact us. We are just one click away, ready to offer you advice and our hands-on expertise.
SCIP Database
Starting January 5, 2021, companies placing articles on the EU market need to provide information to the EU “Substances of Concern In articles as such or in complex objects (Products)” (SCIP) database on articles which contain Candidate List substances (Substance of Very High Concern (SVHC)) in a concentration above 0.1% w/w. The SCIP database has been established under the EU Waste Framework Directive (WFD, 2008/98/EC amended by Directive (EU) 2018/851) and in addition to the existing obligations for SVHCs under EU REACH.
Information regarding the articles need to be provided by EU producers and assemblers, EU importers and EU distributors of articles and other actors in the supply chain placing articles on the EU market.
Retailers and other members of the supply chain providing articles directly to consumers are not obliged to provide information to the SCIP database.
What must be notified? – Requirements for SCIP notifications
The SCIP notification includes information on article identification (identifiers, name, article category), safe use information, and information on the SVHC in the article itself. The submission of the notification has to be done in a specific SCIP-format using the IUCLID Cloud in the online ECHA Submission Portal. The notification is required regardless of volume of SVHC placed on the market.
What is an article?
According to REACH, an article is an object which during its production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition. A “complex object” is an object made up of more than one article. Articles that are assembled or joined together in complex objects remain articles, as long as they keep a special shape, surface or design, or as long as they do not become waste.
Important note: Packaging is also considered an article under REACH.
Our SCIP Services
- Portfolio Analysis: determining which products in your portfolio are considered articles or contain articles
- Article Information Review: reviewing all available compliance information (i.a. compliance statements, safety data sheets, test reports, etc.) to identify potential SVHCs in your articles
- SVHC Likelihood Assessment: verifying the likelihood of finding SVHCs in your articles, based on the raw materials used
- Data Gap Analysis : detecting possible data gaps and specifying recommended actions to close them
- SCIP notification strategy, including intelligent testing strategies for SVHCs
- SCIP notification dossier: compiling SVHC information in IUCLID format and submitting it to the ECHA
Important note: The candidate list is updated every 6 months. Parts of this process have to be repeated every 6 months to determine new data gaps.
Consortia management and SIEF work is still required after the last REACH phase-in deadline of May 2018.
In your role as lead registrant for a substance you may need to lead and run a SIEF or consortium, but lack the experience or the resources to do so well. We are experienced in efficiently managing consortia and SIEFs on behalf of our customers and have enjoyed high industry trust for many years.
Our spectrum of services ranges from setting up consortia/SIEFs and handling trust accounts to data collection and archiving, and handling confidentiality and data compensation issues. We can also represent clients in consortia and SIEFs managed by a third party and cover all technical, scientific and regulatory aspects.
New members may wish to join the SIEF or consortium, LoAs may need to be calculated and issued or the cost shares for new studies performed on request by ECHA may need to be calculated. Since SIEFs and consortia must remain operational, it is essential that they have their contracts checked for validity after the registration deadline of May 2018. Let us handle the entire consortia and SIEF management for you. We have the expertise you need.
Our Classification and Labelling (CLP) Services
The Classification, Labelling and Packaging (CLP) Regulation ((EC) No 1272/2008) is based on the United Nations’ Globally Harmonised System (GHS). It requires manufacturers, importers or downstream users of substances or mixtures to classify, label and package their hazardous chemicals appropriately before placing them on the market. With the release of the Delegated Regulation 2023/707 amending the CLP Regulation, the EU set out new hazard classes:
- Endocrine disruption for human health, Category 1 and 2
- Endocrine disruption for the environment, Category 1 and 2
- PBT (persistent, bioaccumulative and toxic) and vPvB (very persistent and very bioaccumulative)
- PMT (persistent, mobile and toxic) and vPvM (very persistent and very mobile)
The new requirements apply to substances placed on the market for the first time on or after 1 May 2025, including new quantities of substances already on the market before that date. Substances placed on the market before 1 May 2025 and already in the supply chain do not need to be reclassified or relabelled until 1 November 2026. For mixtures, the new deadines apply from 1 May 2026 and 1 May 2028 respectively. According to Commission Implementing Regulation (EU) 2020/1435, Article 6(2), registrants have 6 months from the decision date to update the classification and labelling to submit their dossier updates in the case of a new or changed self-classification. Detailed information can be found on the ECHA website.
C&L Inventory notifications
The CLP regulation also requires manufacturers and importers to notify and submit classification and labelling information for the hazardous substances they are placing on the market to the Classification and Labelling (C&L) Inventory of ECHA. A substance must be notified within one month from being placed on the market.
Our Services
- Classifications of substances and mixtures according to EU CLP Regulation 1272/2008 on the basis of available data
- Advice on the assessment of new hazard classes (ED, PMT/vPvM and PBT/vPvB)
- Preparation of Harmonised Classification and Labelling (CLH) dossiers
- Expert support and follow-up throughout the EU CLH process
- Commenting during consultation
- Representing clients as stakeholder expert in RAC meetings
- C&L Inventory notifications
- Poison Centre Notifications (PCN)
EU REACH regulatory and scientific support
REACH ((EC) 1907/2006) is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals. REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1 June 2007.
Since then, we have prepared more than 700 lead dossiers for phase-in and non-phase-in substances. We handled more than 50 PPORD notifications, far more than 1,000 (late) pre-registrations / inquiries and well over 1,000 CLP notifications. We bring long-standing experience with intelligent testing strategies, read-across, data bridging, QSAR, group/category approaches, PBT/vPvB assessment as well as planning and monitoring of all dossier-relevant studies.
Testing packages
In cooperation with international GLP-certified laboratories, we can offer you testing packages at highly competitive prices, including professional and independent monitoring by SCC experts.
Chemical substance coverage
We are experienced in and can support you with the registration of all types of substances, such as mono and multi-constituent substances, nano-materials and UVCBs, both inorganic and organic.
EU REACH regulatory tools and models
We have excellent and long-standing experience with all regulatory tools and models used under EU REACH, such as IUCLID, REACH-IT and risk-assessment tools such as Chesar, EASYTRA, ConsExpo, Stoffenmanager®, Advanced Reach Tool (ART) and RISKOFDERM.
Evaluation process guidance
Our experts support and guide our customers through the entire evaluation processes handled by ECHA and the Member States, including CoRAP, SVHC and CLH dossiers.
Our REACH services at a glance
Alongside regulatory & scientific support, we cooperate with our partner GBK Regulatory Compliance to round out our services by offering solutions to our customers to meet their technical and documentation needs, such as safety data sheets, poison centres notifications and hazardous goods services.
Don't hesitate to contact us to learn how we can help you twith your chemical compliance.
UK REACH
Important:
On July 20, 2023, HSE officially confirmed that the currently scheduled deadlines for substance registration have been extended by 3 years to 27 October 2026, 27 October 2028 and 27 October 2030 depending on tonnage and toxicity. |
From January 1, 2021 onwards, companies placing chemical substances on their own or in a mixture in quantities above 1000 kg per year on the UK market have to register their chemical substances under the UK REACH regime. This does not apply to Northern Ireland (NI): Companies in NI maintain their EU REACH status and obligations for the duration of the Northern Ireland Protocol, enabling them to continue placing their products on the EU market, on the one hand, and providing them ongoing UK market access for existing NI-based EU REACH registrations for qualifying NI goods (QNIG), on the other.
UK REACH maintains the aims and principles of EU REACH. Having a legal entity in the UK or Only Representative (OR) is a minimum requirement for a registration. The Health and Safety Executive (HSE) acts as the lead UK regulatory authority under UK REACH.
The UK government has extended the deadlines currently provided in UK REACH legislation for submitting data for certain use cases. The deadlines are specified below.
For more information, please visit the UK government website.
EU or non-EU based companies
An EU based or non-EU based company exporting to the UK can register its substances under UK REACH through a legal entity in the UK, via its UK importer or an UK-based OR.
Current UK Downstream Users under EU REACH, act as importers under UK REACH of non-UK REACH registered substances. To continue importing substances from the EU to the UK, downstream users were asked to identify their intention to register by submitting a Downstream User Import Notification (DUIN) before October 27, 2021. Downstream users who have submitted a DUIN have been automatically granted additional 2 to 6 years to prepare a full data set for substance registrations depending on the tonnage band and hazard profile of the substance.
Even though the official DUIN deadline expired in late October 2021, HSE is still accepting notifications. With a new deadline haven't been set, HSE recommends to submit a notification as soon as possible.
Deadline for registration | Tonnage band | Hazardous property |
27 October 2026 | 1000 tonnes or more per year | Carcinogenic, mutagenic or toxic for reproduction (CMRs) – 1 tonne or more per year Very toxic to aquatic organisms (acute or chronic) – 100 tonnes or more per year Candidate list substances (as at 31 December 2020) |
27 October 2028 | 100 tonnes or more per year | Candidate list substances (as at 27 October 2023) |
27 October 2030 | 1 tonne or more per year |
The Department for Environment, Food & Rural Affairs (Defra) is currently consulting on extending the submission deadlines. The first deadline due on 27 October 2023 is discussed to be extended for three years, until October 2026. The public consultation ends on 1 September, the decision is awaited later in the fall.
Our UK REACH services for EU and non-EU based companies
For EU and non-EU based companies, we can offer the following chemical regulatory services for the UK market:
- Only Representative services through our local legal entity in the UK
- Registration support, including Article 26 inquiry
- Legal services related to EU REACH Letter of Access (LoA) issues by
- Developing a regulatory strategy, including a testing strategy for UK registrations
- Taking care of your communication with potential registrants of substance groups
UK based companies
Under UK REACH, existing EU REACH registrations held by UK-based companies (including registrations held by an existing OR) have been automatically carried across into UK REACH (‘grandfathered’). The deadline for the submission of basic data about the company and the substance ended by April 30, 2021. Full information, appropriate to the tonnage band and hazard profile, will need to be submitted according to the registration deadlines set per tonnage band and hazard profile over a period of 2, 4 or 6 year, as the HSE will no longer have direct access to the substance data held by the ECHA.
Companies based in the UK and importing non-UK registered chemical substances are required to register their substances under UK REACH. Registration obligations can be avoided, if the EU or non-EU based supplier appoints an OR and takes responsibility for the UK REACH registration obligation.
Our UK REACH services for UK based companies
For UK based companies, we can offer the following chemical regulatory services for the UK market:
- Registration support for substances
- Developing a regulatory strategy, including a testing strategy for UK registrations
- DUIN notification and Article 26 inquiry support
- Legal services related to EU REACH Letter of Access (LoA) issues by
- Taking care of your communication with potential registrants of substance groups
Contact Us
Contact our experts to learn more about our services for UK REACH and how we can help you make your chemicals fit for the UK market.
Poison Centre Notifications and CLP regulation (EC 1272/2008 )
According to Annex VIII to the CLP regulation (EC 1272/2008), importers and downstream users placing hazardous mixtures on the EU market must notify their products to the nationally appointed bodies. This EU Poison Centre Notification is a legal obligation neither covered by existing REACH or CLP notifications. The notification has to be submitted in each Member State where the mixture is intended to be made available on the market. Annex VIII establishes compliance deadlines for Poison Centre Notifications depending on the type of their use:
- Consumer and professional use (since 1 Jan. 2021)
- Industrial use (by 1 Jan. 2024)
To allow the appointed national poison centres to unequivocally identify the concerned mixture(s) in case of a reported emergency, a harmonized format for notifications have been created, along with a Unique Formula Identifier (UFI) which needs to be placed on the product label.
We can help you take care of your Poison Centre Notifications.
Our Services for Chemicals
Our experts provide you with full-scale support for your chemical regulation needs on the international level.
Contact our experts
They answer your questions and advise you on how you can make your chemicals fit for your target markets.
Fill out the form below or contact us by This email address is being protected from spambots. You need JavaScript enabled to view it. or phone (+49 671 298460).
Safety Data Sheets
Safety Data Sheets (SDS) are standardised documents prepared by manufacturers and importers of hazardous chemicals in line with the Globally Harmonised System of Classification and Labelling of Chemicals (GHS). SDS provides information on product identity, health and physical hazards, safe handling and storage guidelines as well as emergency procedures and disposal considerations. The ground rules of SDS compilation are stipulated in Article 31 (requirements of safety data sheets) and in Annex II (Guidance on the compilation of safety data sheets) of the REACH Regulation (EC) 1907/2006.
In the current continuously changing regulatory world, in a multinational and multilingual market, SDS preparation can prove to be a demanding task, requiring companies responsible for the correctness and completeness of their safety data sheets to stay always up-to-date and aware of recent requirements.
Our experts can take care of your SDSs. In cooperation with our renowned partner, GBK GmbH Global Regulatory Compliance, we advise you on SDS compliance. We produce and review for you your safety data sheets, as well as prepare annexed exposure scenarios (eSDS).
Our Services for Chemicals
Our experts provide you with full-scale support for your chemical regulation needs within and outside Europe.
Contact our experts
They answer your questions and advise you on how you can make your chemicals fit for your target markets.
Fill out the form below or contact us by This email address is being protected from spambots. You need JavaScript enabled to view it. or phone (+49 671 298460).