Chementors at Chembio 2022 Expo
Work the Nordic Way Exhibition 2022
Four new hazardous chemicals added to the Candidate List in January 2022
Four new chemicals have been added to The Candidate List of substances of very high concern as of 17th January 2022. The Candidate List now contains 223 entries for chemicals that can harm people or the environment (SVHC). Companies are responsible for managing the chemicals safely and providing sufficient information to their customers and consumers.
One of the four substances is used in cosmetics and has been added to the Candidate List as it has hormone-disrupting properties in humans. Two are used, for example, in rubbers, lubricants and sealants, and have been included because they negatively affect fertility. The fourth is used in lubricants and greases and has been added as it is persistent, bioaccumulative and toxic, and therefore harmful for the environment. More infomation on ECHA’s website.
These substances may be placed on the Authorisation List in the future. Inclusion on that list means that the use of the substance is prohibited unless a company receives an authorisation to continue its use from the European Commission.
Chementors offers a service for SVHC substances and Declaration of Compliance.
The registration requirements for the REACH Regulation changed in January 2022
Tukes informs that the information requirements under REACH Regulation have changed starting from 8.1.2022. The amending Regulation (EC Regulation 2021/979) changed Annexes VII-XI of the REACH Regulation (EC 1907/2006), clarifying some of the information requirements and the responsibilities and roles of ECHA and operators.
In addition, the general rules of the standard testing program in Annex XI and the possible non-testing have been clarified. The amended provisions may require operators to update the registration dossier.
Registration under REACH (EC Regulation 1907/2006) provides information on the properties of the substance. The minimum information to be provided to fulfill the registration obligation is called the standard information requirements. Annexes VII to X contain standard information requirements for substances manufactured or imported in quantities of 1 to 1 000 tonnes or more per year. Annex XI sets out the general criteria for the adaptation of the standard information requirements.
Please contact us if you need help with REACH matters or the aforementioned new changes. Chementors offers a wide range of REACH services tailored to your needs!
Upcoming changes to REACH information requirements
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.
SCIP notifications of SVHC substances on the EU market
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
Find out more about SCIP notifications and contact us for further information and assistance.
Poison Centre Notifications are here
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.
SVHC Candidate List update: Four new hazardous chemicals to be phased out
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.
See here the full details of the added substances.
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.
Background
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)
Vietnam is updating their National Chemical Inventory
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.
What is the UFI code?
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.