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About the author Antti Aalto

SVHC Candidate List update: Four new hazardous chemicals to be phased out

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

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.

A huge failure rate to notify customers on Substances of Very High Concern

A huge failure rate to notify customers on Substances of Very High Concern

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.

Original article by ECHA 

ECHA proposes 18 substances for authorisation

ECHA proposes 18 substances for authorisation

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.

Changes to substances permitted in cosmetic products

Changes to substances permitted in cosmetic products

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 proposes to restrict intentionally added microplastics

ECHA proposes to restrict intentionally added microplastics

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.

ECHA added six new substances to SVHC Candidate List

ECHA added six new substances to SVHC Candidate List

Helsinki, January 15, 2019

The Candidate List of substances of very high concern (SVHCs) for authorisation now contains 197 substances.

ECHA has added five new substances to the Candidate List due to the carcinogenic, toxic to reproduction, persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) properties of the substances.

One further substance has also been added to the list having been identified as an SVHC by the European Commission due to its endocrine-disrupting properties. The Commission’s decision follows the referral of the MSC opinion on this SVHC proposal in 2016.

Read ECHA’s news article from here.

SVHC Candidate list can be found here.

We have REACHed the deadline!

We have REACHed the deadline!

The final legal deadline to REACH register all phase-in substances manufactured or imported above one tonne per year was May 31st. If the registration obligation applies and companies did not submit a dossier by the last day of May, as of 1 June they can no longer manufacture or import the substance legally in the EU/EEA.

Chementors helped numerous Finnish and other EU companies, including many SMEs, as well in capacity of our role as legally appointed Only Representative for non-EU manufacturers, successfully submit their registrations for the final REACH deadline. It’s a true milestone and precedent to safeguarding our common future! So congratulations are in order.

We expect companies to finally realise REACH registration being a true business asset with a clear business advantage delivering a return on investment. Companies that registered can have guarantied access to the substances they depend, or your customers rely on, Non-EU companies who registered with Only Representatives will have access to the EU market. Lastly but not least, the added confidence provided now in knowing the relevant risk management measures that ensure safe use. Other positive side effects is that companies worked together sharing costs and avoided animal testing to a minimum. In addition, REACH is to stimulate R&D and innovation to find safer alternative substances and solutions to benefit us all

What will happen after 31 May 2018, as registration is just the first step in sound chemicals management?

There are further obligations to consider under REACH, not just concerning the duty to register. Indeed, registration itself even is not simply a one off task as it is living its dynamic just as are your business and portfolio. You are responsible for the safe use of your chemicals, must maintain compliance with REACH including to keep your registration up-to-date and accordingly implement and/or communicate any safe use recommendations – and this should be really happening and not ignored.

Enforcement is the key! It will really kick-off and becomes more apparent, more strict and more consistent – as it is required to ensure fairness to those complying with the law. Awareness of REACH will continue to grow among managers, workers, retailers, consumers and the public in general. Also other parts of the globe will be following as they are already.

ECHA will be busy checking the quality of the data submitted in the registrations, identifying non-compliant dossiers and also verifying company sizes if they really are an SME. Additionally Member States will also be carrying out substance evaluations to investigate certain concerns and may request even further information beyond the standard requirements. Ultimately further EU regulatory actions may be deemed necessary.

Registrants and companies in general should be vigilant in order to be forewarned and react in due time. So far a majority of registrations submitted by companies are not adequate in quality, resulting that companies are urged to proactively and voluntarily revise and update the registrations. They are given reminder being responsible and liable of their registrations.

European Chemicals Agency (ECHA) have shared some tips for post-registration actions:

  • Implement and ensure Risk Management Measures and further information for safe use is followed (capacity as registrant & user or downstream user of chemicals as such in formulations)
  • Communicate important information – consider if your Safety Data Sheets should be updated OR other measures to informing downstream end users in the supply chain including consumers
  • Aim to incorporate REACH matters and principles in your own overall day to day business activities and planning, synergising with other in-house management system, or policies
  • Implement in-house training if necessary and be prepared for any inspections
  • Make a plan for keeping your registration up to date. Keep track of new data, potential new uses for your substance and volumes produced or imported.
  • Make sure you have access to your REACH-IT account (login details, set up e-mail notification alerts, back up contact person) – ECHA communicates officially to registrants via REACH-IT.
  • Have a platform to collaborate with your other co-registrants to deal with new registrants and requests for more information from authorities.
  • Submit an inquiry for each new substance you place on the market in quantities over one tonne per year.
  • Follow the authorities’ work: check your portfolio for substances that are subject to regulatory action and see whether safer alternatives are available
  • Seek help if needed, its available – from national helpdesks, ECHA helpdesk, Guidance documents, YouTube videos, industrial associations, laboratories
  • ECHA acknowledges the importance of support provided by consultants and specialists since certain tasks are not straightforward, or companies simply don’t have the in-house capabilities or time. ECHA published a checklist helping you to select a suitable and reputable consultant

Chementors can help companies to review and update their registrations with the newest IUCLID format version while offering the benefit from all the experience gathered, as well as ECHA and sector feedback and advice now available. Chementors mentors companies in all roles and in multiple areas to concern chemical and product compliance management. Should you have any doubts or questions, please do get in touch. Our clients trusts us with their business.