The European Commission has revised certain information requirements for registering chemicals under REACH. The changes will start to apply in early 2022 and companies need to start preparing. ECHA will publish more advice in late 2021.
- requirements for surface tension and water solubility of metals and sparingly soluble metal compounds;
- requirements for in vitro testing for eye irritation and in vivo testing for skin or eye irritation;
- requirements and adaptations for 28-day and 90-day repeated dose toxicity studies;
- specific rules for adapting reproductive toxicity studies;
- general rules for adaptation based on:
- use of existing data;
- weight of evidence;
- substance-tailored exposure-driven testing; and
- grouping of substances – in particular, those of unknown or variable composition, complex reaction products and biological materials (UVCBs);
- new rules for adapting studies on fate and behaviour in the environment based on a low octanol-water partition coefficient;
- new specific rules for adapting for dissociation constant and viscosity; and
- additional requirements for human health and environmental testing to be performed at appropriately high dose levels.
EU importers and EU manufacturers now have obligations according to the REACH Regulation ((EC) No 1907/2006) and the Waste Framework Directive (2008/98/EC) which requires the determination of chemicals contained in their products. During this process it is important to submit a SCIP notification to the European Chemical Agency (ECHA), if certain regulatory criteria are met.
The SCIP notification obligation facilitates the flow of information on substances of very high concern (SVHCs) in articles. The aim is to make information on SVHCs more available during the product life cycle, including the waste phase. In addition, the database aims to promote the substitution of SVHCs by safer alternatives.
The SCIP notification obligation applies to suppliers of articles if the article contains more than 0.1% by weight of SVHC. Manufacturers and assemblers, importers and distributors in the EU and other actors in the supply chain who place articles on the EU market are required to submit the notification. Dealers who supply articles directly and only to consumers are not required to submit data to the SCIP database
Since 1 January 2021, importers and downstream users are obligated to notify their mixtures in a harmonised format and unique formula identifiers (UFIs) must be included on mixture labels. This is an important change for companies placing hazardous mixtures on the market.
Most EU countries are now accepting notifications through the ECHA Submission portal. ECHA’s overview of Member States that accept them is updated regularly. The overview and contacts of the national authorities can be found on ECHA’s national support page.
Almost 350 000 notifications were submitted by the year end via the ECHA Submission portal, although the duty to notify in the harmonised format only took effect on 1 January 2021. In addition, ECHA Helpdesk received more than 1 000 questions related to poison centre notifications in the past few months.
Chementors is fully equipped with expert knowledge and software solutions for the Poison Centre Notifications. Contact us for help and information about our PCN service for tailored assistance based on your notification needs.
The Candidate List of substances of very high concern (SVHCs) for authorisation now contains 209 substances.
Helsinki, 25 June 2020 ECHA – The four candidate substances includes an endocrine-disrupting substance, that is used in consumer products, such as cosmetics. The three others are used in industrial processes to produce polymers, coating products and plastics, respectively.
Companies are urged to check their legal obligations relating to the safe use of their substance. From January 2021, companies will also have to notify products containing SVHCs to ECHA’s upcoming SCIP database on substances of concern in articles and products. The database aims to ensure transparent information on articles containing hazardous chemicals throughout their whole life-cycle.
The Candidate List includes substances of very high concern that may have serious effects on our health or environment. These may be placed on the Authorisation List in the future, which means that industry would need to apply for permission to continue using them.
Companies may have legal obligations when their substance is included in the Candidate List – either on its own, in mixtures or in articles. Any supplier of articles containing a Candidate List substance above a concentration of 0.1 % weight by weight has to give sufficient information to their customers and consumers to allow safe use. As of January 2021, companies will also need to notify ECHA’s SCIP database if their articles contain Candidate List substances.
Importers and producers of articles containing a Candidate List substance also have six months from the date of its inclusion in the list (25 June 2020) to notify ECHA.
(Original text by ECHA)
While getting back into business after lifting nationwide lockdown aka social distancing, Vietnam has started to update their National Chemical Inventory.
The Ministry of Industry and Trade (MOIT) of Vietnam published the new drafted National Chemical Inventory (NCI) in March 2020. Originally established in September 2016, NCI currently includes 36,777 substances and is organised and maintained by Vietnam Chemical Agency (Vinachemia).
Vinachemia is now accepting additional chemical information to NCI portal and substance nomination can be submitted until 30th of May, 2020. Requirement is that substances which are submitted during this update must be currently imported by Vietnamese industry.
Following information should be provided related to the chemical substances:
- Name and CAS number of the substance
- Safety data sheet (SDS) in Vietnamese
- Documents proving that substance is used/marketed in Vietnam
- Sales contract with Vietnamese importer, or
- Sales invoice (financial figures concealed)
- Technical data of the substance for comparison and determination of the substance ID.
- Estimated annual tonnages of import to Vietnam
Substances not submitted by the deadline, according to the chemical management plan, will be treated as a new substance in Vietnam after Vinachemia has finalised the NCI. Therefore, we strongly recommend listing all relevant substances which you are currently selling to Vietnam in order to avoid any issues with the import at a later stage.
Chementors SEA Ltd. is our local branch in Vietnam (Ho Chi Minh City) and able to assist you to prepare all needed documents for adding your relevant substances to the NCI portal. Find our contact information here.
UFI is an acronym for Unique Formula Identifier. The UFI will primarily be used by poison centres in the event of an emergency call. For example, the UFI can be read directly from the label of a product to a poison centre operator in addition to the trade name to precisely identify the product involved in an incident.
The UFI code must either be printed or affixed to the label of all products containing hazardous mixtures. If the products are not labeled (this is the case with certain industrial products), the UFI identifier can be also found in the safety data sheet.
Importers and downstream users who place hazardous mixtures on the market must provide the poison centers with specific product information of the mixtures, including the UFI. You can find the UFI Generator and the user guide on ECHA’s Poison Centres website in 23 EU languages.
For mixtures not yet on the market, your obligations to submit harmonised information and place the UFI on the label will apply from:
- 1 Jan 2021 (consumer use)
- 1 Jan 2021 (professional use)
- 1 Jan 2024 (industrial use)
If you have existing mixtures already on the market, you may benefit from a transitional period which ends 1 Jan 2025. This means that after this date, all mixtures classified for health or physical effects will be required to bear the UFI on the label.
Companies have a lot to improve on reporting harmful substances in their products
The ECHA Enforcement Forum pilot project revealed shortcomings in the notification of SVHCs in their products.
Good news about the pilot project is the fact that only 12% of the products examined contained SVHCs. In contrast, 88% of companies whose products were found to contain SVHCs failed to comply with their reporting obligations.
The Enforcement project comprised nearly 700 articles, more than 400 companies, in 15 different EU countries. The focus was on industries whose products are most likely to contain harmful substances. The checked products included clothing, footwear and home textiles; wires, cables and electronic accessories; plastic or textile floorings; wall coverings; and other plastic and rubber products.
Head of the ECHA’s Support and Enforcement Unit, Erwin Annys said that “The report clearly shows a failure of communication in the supply chain and improvement is needed if we want to make REACH work in all aspects.”
The ECHA Secretariat and the Forum will further analyse the results from this enforcement project and the recommendations included in the Forum’s final report, and consider further actions that could improve the situation.
18 substances of very high concern (SVHCs) are recommended to be added to the REACH Authorisation List
Helsinki, 1 October 2019 – ECHA’s ninth recommendation to the European Commission to prioritise substances of very high concern for authorisation includes 18 substances. Thirteen of these substances are toxic for reproduction, of which one has also endocrine disrupting properties. The other substances are an endocrine disruptor, a carcinogen, a very persistent and very bioaccumulative (vPvB) substance and two respiratory sensitisers.
The substances have been prioritised from the Candidate List because of their intrinsic properties in combination with high volume and widespread uses, which may pose a threat to human health or the environment. Some of these substances are currently not used in the EU but could replace other substances recommended for the Authorisation List (Annex XIV). Their inclusion should avoid regrettable substitution.
Original article here.
With the new EU regulation, more than 200 substances or groups of substances were banned in cosmetic products. Cosmetics marketed in the EU and EEA countries must not contain these prohibited substances or must comply with restrictions on their use. Prohibited substances are carcinogenic, mutagenic or toxic to reproduction (CMR).
On 22 May 2019, the European Commission published a new Regulation (EU) 2019/831 which amended Annexes II, III and V of the Cosmetics Regulation and became applicable on 12 June 2019. Therefore, cosmetic products sold in Finland or elsewhere in the EU / EEA or marketed in Finland via the online store may no longer contain substances prohibited by the Regulation or the substances must comply with the restrictions on their use.
The EU Cosmetics Regulation bans the use of CMRs in cosmetics. Substances are classified as CMRs according to EU chemicals legislation *. The hazardous properties of a substance do not always pose a risk to health. CMRs can be used in cosmetics if the European Commission Scientific Committee, based on a risk assessment, concludes that the use is safe under certain conditions. The prohibition or restriction on the use of cosmetic products is implemented by amending the annexes to the EU Cosmetics Regulation (Commission Regulation (EU) 2019/831) by adding the names of banned or restricted substances in the annexes. The EU Cosmetics Regulation and its annexes are also directly applicable in Finland.
Find the full TUKES article here (In Finnish).
If you would like more information about the Brexit phases, you can also visit the European Chemicals Agency website – information is available here.
ECHA has submitted a restriction proposal for microplastic particles that are intentionally added to mixtures used by consumers or professionals. If adopted, the restriction could reduce the amount of microplastics released to the environment in the EU by about 400 thousand tonnes over 20 years.
Helsinki, 30 January 2019 – ECHA has assessed the health and environmental risks posed by intentionally added microplastics and has concluded that an EU-wide restriction would be justified. If adopted, the restriction could result in a reduction in emissions of microplastics of about 400 thousand tonnes over 20 years.
ECHA’s assessment found that intentionally added microplastics are most likely to accumulate in terrestrial environments, as the particles concentrate in sewage sludge that is frequently applied as fertiliser. A much smaller proportion of these microplastics is released directly to the aquatic environment.
Find full ECHA’s article from here.