Chemical

Unclaimed Notification of New Substances

As you all know NONS (Notification of New Substances) was the procedure to “register”, better notify, chemical substances to EU Member States before the advent of the REACH regulation (EC n. 1907/2006) and following EC Directive 67/548 and following amendments. Existing NONS were requested to be transferred to the new REACH system by applying the Art. 24 of the new regulation. With such procedure the old dossiers (done by DES software) were transferred into the new REACH regulation by companies using the experimental data and information already mentioned in such dossiers.As mentioned in ECHA’s latest 5-yearly report on the operations of REACH and CLP, there are several issues with NONS registrations:

  • 92% of them do not cover the standard information requirements according to REACH Reg. Indeed, REACH foresees that dossiers complying with the standard information requirements need to be submitted to ECHA only when NONS registrations are updated to increase the tonnage band, which so far happened for 8% of NONS registrations. This issue will remain unless the legal text is changed.
  • 68% of them are not in joint submissions and not updated. Issues arise when new registrants take the lead registrant role in REACH-IT and create a joint submission. After that, NONS registrants cannot update their NONS registration anymore without first joining the joint submission.
  • 48% of them are “unclaimed NONS”, i.e. NONS notifications for which no company claimed ownership after they became registrations under REACH. These unclaimed NONS impose, therefore, some action to better comply with REACH

 

Over the past 12 years, 5.225 NONS registration numbers were claimed by their owners, thereby confirming them as registrations under REACH. After the initial peak of NONS claiming in 2008-2010, NONS registration numbers are currently being claimed at a rate of about 4 per year with 4.739 NONS registration numbers still unclaimed (see following Figure)

Considering that companies have had extensive time to claim the NONS registration numbers assigned by ECHA in 2008, and the diminishing returns on the NONS claiming in the past years, ECHA will put an end to this process in 2022.

To ensure that companies’ expectations of being able to confirm ownership of NONS registration numbers are duly respected, ECHA will launch a campaign informing companies of the end of the NONS claiming period and will provide an additional 6-month period for completing the process of claiming any outstanding NONS registration numbers. For notifiers of unclaimed NONS only postal contact details from 2007 are available, and hence the campaign will focus on raising awareness via the ECHA website.

After the 6-month period, ECHA will remove the possibility to confirm ownership of unclaimed NONS registration numbers.

At the same time, the NONS registration numbers for which the assignment process has not been completed – i.e. numbers that have been created by ECHA but have not been claimed by the NONS notifiers – will be marked accordingly in ECHA’s IT systems. Such a change in status will inform that the registration number was left unclaimed, and no legal entity is associated with that registration.

ECHA plans to communicate on its website in Q3-4 2021 about ending the NONS claiming period and the consequences for the unclaimed NONS. After a 6-month period for companies to claim any remaining NONS – or inform ECHA which ones they intend to claim but are having technical difficulties with – ECHA will close the process and change the status of the registration numbers that had not been confirmed by any former notifier, in 2022.

Afterwards, the NONS claiming module will be removed from REACH-IT and support material will be updated accordingly.

Companies needs to check and react accordingly!

 

Revision of the Reg. EC n. 1907/2006 is expected

 

Along the last 2-3 years, an intense debate has occurred over the systematic revision of the REACH regulation (EC Reg. n. 1907/2006) to adapt it to the scientific progress concerning some specific scientific/regulatory assessments and, on the other hand, to modernize it based on the huge experience due to its multiannual application (since 2007). Two main actors are involved in such a debate: the EU Competent Authorities, mainly EU Commission, ECHA and Members states on one side and the industry representatives on the other side. Their legitimate visions and experiences acquired during the 14-year application need to reach a shared synthesis in the new expected Regulation. Other stakeholders involved in such revision are indeed the Scientific Community (which needed support for topics as Endocrine Disrupting Chemical and combined Risk Assessment of substances and mixtures) and the Civil Society (all of us), who are the ones who benefit from the practical application of the Regulation. Moreover, the REACH revision will also be the result of the recently announced EU strategies concerning the European Green Deal towards a toxic-free environment and the Circular Economic strategy to reduce chemical production, avoiding SVHC (Substances of Very High Concern) chemicals in recycled materials. Many other topics will affect such REACH revision, even not directly concerning chemical safety.
Among these, we can mention:
§  Batteries Directive mainly in relation to the expected development of e-cars and electronic devices in general
§  The EU strategic approach to pharmaceutical into the Environment (PIE)
§  Occupational Safety and Hygiene (OSH) legislation
§  Waste legislation in connection with the Circular Economy strategy and the problem of SVHC in articles
§  EU ecolabel
§  Drinking water§  Fertilizers§  Connection with the 7th Environmental action plan.

The year 2022 (15 years after the first application) is awaited for the new regulation release. The two actors have different views on the content and principles of this new document. EU Commission seems to be oriented to a partial revision of the Regulation with an extension of the application of SVHC, polymers and mixtures, and a simplification of some processes like restriction and authorization; the industry is not favouring a complete revision but only for some focused topics. Industry evokes a more balanced strategy and not a complete revision of the REACH regulation that can increase chemical companies’ burden again. A balanced strategy means a document that can integrate the hazardous properties of the chemical substances that need to be well known and manage. With their risk assessment and considering the huge benefits, chemical substances can drive a safe environment and a good Circular Economic application. The industry does not agree with the use of statements like “toxic-free” and “non-toxic”, preferring “safe” and sustainable”. Theoretical versus practical approach? A dialogue is hence necessary before the release of the new document! The main regulatory matters that are expected to be implemented in the REACH Revision 2022 are the following:

§  Combined exposure.
§  Polymers and polymers of concern.
§  EDS Endocrine Disrupting Substances.
§  Chemical substance and environment.
§  Waste, SVHC and recovered substances.
§  Dossier quality and update.

 The expectations for REACH regulation review in 2022 is very high. Most of the listed topics have been discussed for years. Some others are moderately new but need attention as well. All together they lead to extensive revision work and a final 2022 document that needs to be a pragmatical synthesis of scientific criteria and regulatory approaches.

Dialogue with main stakeholders is essential. The 2022 REACH regulation may have crucial consequences and impact various sectors, including society.

All stakeholders are invited to contribute to a successful final release in the future European strategies for Green Deal, Circular Economic, and a future safer environment.

 

 

Borderline products: cosmetics or disinfectants?

 

Francesca Fasano, Head of BU Chemical in Chemsafe, has published an article on HPC TODAY – FIRST ISSUE OF 2021.

Abstract:

In 2020 due to the spread of COVID-19, the market experienced a sudden request of products for hand washing, which caused shortage of products. Several companies looked with interest at this market portion. The main problem was to understand which regulation to follow, the cosmetic regulation or the biocidal product regulation. Both regulations may apply, it is matter of economic and marketing strategy to choose between them. This paper gives a quick overview of the differences in terms of requirements, costs, time and claims between the regulation, to help companies to make their choice.

JANUARY/FEBRUARY 2021 VOL 16(1) pg. 41.

Read the entire article here: https://www.teknoscienze.com/Contents/Riviste/Sfogliatore/HPC1_2021/42/

 

The ECHA Opens up the SCIP Database to the Public

 

The SCIP is the database for information on Substances of Concern In articles as such or in complex objects (Products), established under the Waste Framework Directive (Directive 98/2008/CE – WFD). The obligation raises from article 9.2 by which the European Chemicals Agency (ECHA) has established the SCIP database by 5 January 2020.

As from 5 January 2021, Companies supplying articles containing substances of very high concern (SVHCs) on the Candidate List in a concentration above 0.1% weight by weight (w/w) on the EU market must submit information on these articles to ECHA. The obligation is very similar to that of REACH article 33 (information of the supply chain about SVCH in an article in a concentration above 0.1%). However, the two obligations are independent and do not exclude each other.

The SCIP notification obligation under the Waste Framework Directive is aimed to ‘ensure that the information about the presence of SVHCs is available throughout the whole life cycle of products and materials, including at the waste stage’. Pay attention that the waste is not considered nor substance nor mixture nor article under REACH. Therefore, waste does not have a Safety Data Sheet or an informative letter pursuant to article 33. Briefly, the informative chain breaks when a product becomes a waste.

On the other hand, the aim of Article 33 is to ensure that sufficient information is communicated down the supply chain to allow the safe use of articles by actors in the supply chain, professional and industrial end-users and consumers. The information, flowing along the supply chain, enables all operators to take, at their stage of the use of the article, the appropriate risk management measures to guarantee the safe use of articles containing Candidate List substances. Therefore, Companies are required to comply with their communication obligation under REACH article 33 and with the SCIP database introduced by WFD.

Despite the intent, the same vulnerability persists in SCIP: if no information is available (and this is the pretty common case of importers) an analytical investigation should be performed. However, at the moment, no standardized method is published by OECD: laboratories have to put in place their own method and, usually, different methods lead to different results. Moreover, the judgment C‑106/14 of the European Court, issued on 10 September 2015, decreed the concept that once an article has been created, it always remains an article. More specifically, the REACH Regulation does not define a “complex article” as an article containing several articles. Therefore, a distinction should not be made between a complex article and a non-complex article. From this, it follows that the qualification as an article is applicable to any object.

Therefore, it is evident that this position heavily affects the management of complex items as the calculation of the 0.1% percentage: it must be carried out on the weight of the single assembled piece and not on the weight of the entire complex article, for example, placed on the market.