GPC Newsletter Feb-2022

ECHA regularly recommends substances from the Candidate List to be included in the Authorisation List (Annex XIV to REACH), based on the information in the registration dossiers on uses and volumes of the substance. On February 2, 2022, ECHA lists eight new substances to be included in the authorisation list. Comments for this proposal are invited until May 2, 2022.  

If a substance is included in the Authorisation List, it can only be placed on the market if an authorization is granted for a specific use and that is after a given date. Below is the eight substances listed by ECHA and companies that are using, manufacturing or importing these substances may have to apply for authorisation if these are added to Annex XIV of REACH regulation. As of now companies can send their proposal for defending the substances for not including it to Authorization list and ECHA will review those comments before taking the final decision on inclusion of these substances into Authorization list.

Under EU Cosmetics Regulation, the commission banned some uses of methyl-n-methylanthranilate as a fragrance ingredient. This is an ingredient usually used in the production of shampoos, soaps, and other beauty products.

In alignment with the initial proposal presented by the Commission last year, the substance is banned from sunscreen products and other products marketed for natural or artificial UV light exposure. The substance is phototoxic; therefore, it shouldn’t be used with nitrating agents. The new restriction also says that the maximum nitrosamine content should be 50 micrograms per kilogram and cosmetic products containing methyl-n-methylanthranilate should be kept in nitrite-free containers.  

However, it is ascertained that there are no safety concerns for this substance in a concentration of up to 0.2% in rinse-off products and up to 0.1% in many leave-on cosmetic products.

Conclusively, from 21^st August 2022, cosmetic products that do not comply with the restrictions should not be placed in the EU market and should not be available from 21^st November 2022.

Last Update: 2022-02-08

The European Commission, after a serious struggle, recently declared resorcinol as an SVHC. This decision was made based on the endocrine-disrupting properties of human health.

This decision was made by a voting process where 19 member states voted in favour and three members voted against, while five member states were absent. Those who voted in favor represent 54% of the EU’s population which is short of the 65% threshold necessary for passing a majority vote. However, the vote was passed considering only three member states voted against the decision, this is below the minimum four that makes up a ‘blocking minority’ under Article 16 of the Treaty on European Union (TEU). 

Following this decision, resorcinol will now be added to the REACH candidate list ending a long battle of adding or not adding the substance to the SVHC list. This struggle has been ongoing since 2020 when the committee couldn’t decide. An agreement wasn’t made because there were disagreements over if the substance causes an equivalent level of concern under REACH as a carcinogenic, mutagenic or reprotoxic (CMR) chemical, or one that is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB).

Resorcinol is a high-volume compound used for producing rubber products, tyres, industrial resins, adhesives, and some cosmetic and medical products. And scientific evidence shows the serious effects the substance has on human health.

You can view the commission implementing decision here and the formal voting results here.

Last Update: 2022-02-14

When UK REACH entered into force, all substances included in the EU REACH candidate list were ipso facto (by the fact itself) transferred into the new UK REACH candidate list. As to the substances added to the EU REACH candidate list after UK REACH entered into force, the UK regulators committed to assess whether these substances should also be added into the UK REACH candidate list.

On December 10, 2021, the UK’s Health and Safety Executive (HSE) and Environment Agency (EA) announced having conducted an assessment of the substances placed into the EU REACH candidate list by ECHA since the entry into force of UK REACH. Out of those, HSE and EA have identified four substance groups that should undergo further assessment:

ü  dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivatives, and any other stannane, dioctyl-, bis(fatty acyloxy) derivatives wherein C12 is the predominant carbon number of the fatty acyloxy moiety

ü  1,4-dioxane

ü  small brominated alkylated alcohols (SBAA)

ü  phenol, alkylation products (mainly in para position) with C12-rich branched or linear alkyl chains from oligomerisation, covering any individual isomers and/or combinations thereof (PDDP)

Following the assessment, the UK regulators will recommend the most appropriate course of action for managing the risks identified from these four substance groups. Such actions may consist in adding the substances into the UK REACH candidate list, although according to the official statement “HSE and EA may make other recommendations.”

Source: Approach to including substances of very high concern on the UK REACH candidate list

On January 31, 2022, the Bureau of Indian Standards (BIS) released a Gazette notification for Extension in the Implementation date of Chemicals under mandatory certification Scheme I. The chemicals with extended implementation dates are Acetic acid, Methanol, Aniline, and Morpholine. For Acetic acid, Methanol, and Aniline, the implementation date extends from January 2022 to August 3,  2022. Whereas, for Morpholine, it is extended till August 1, 2022.

GPC has BIS-related services and can help you (end-to-end) in getting a BIS registration certificate for your product. 

Gazette notification for Extension

The Department of Chemicals and Petrochemicals (DCPC) in India has pushed back the deadlines for implementing quality control orders (QCOs) issued by the Bureau of Indian Standards (BIS) for five substances. These substances are tagged ‘specialty’ chemicals by the BIS and the deadline is now June 22, 2022, rather than December 21, 2021, as originally planned.

These five substances are:  

· Phthalic anhydride 

· Ethylene glycol

· Toluene 

· Terephthalic acid, and 

· N-butyl acrylate. 

The DCPC, on the 24^th of December, issues separate notifications for each chemical saying the government, after consultation with BIS, agrees that an extension is needed in the public interest. This is also attributed to the difficulties government officials are facing regarding samples collection, laboratory tests, products certification due to COVID related travel restrictions.

Therefore, manufacturers, importers, and traders of these chemicals can continue to operate under prevailing trade regulations until the new deadline set as June 22, 2022. Until then, manufacturers and distributors will have to carry relevant BIS Indian Standard (IS) specification numbers and markings on their packaging and labels.

Last Update: 2022-02-16

Till the 16^th of March 2022, the Bureau of Indian Standards (BIS) consults on the draft Indian Standard (IS) for 3,4-dichlorophenyl isocyanate. BIS published a daft in February, describing the substance as an organic compound (formula: C7H3CI2NO) used as an intermediate in organic synthesis.

This compound is irritant to many tissues which include the eyes and mucous membranes. Also, inhaling the chemical dust can result in respiratory harm. The draft includes requirements, methods of sampling and testing for the chemical. In addition to that, one has to adhere to the provisions in the following standards:

The other proposals in the draft include the following:

·       For packing, the substance should be kept in suitable drums, tankers, ISO containers, etc. depending on the agreement between the purchaser and supplier.

·       For marking, the container should bear the name of the material, name of the manufacturer and his/her recognized trademark, month and year of manufacture, lot/batch number, net weight & gross weight, label (acute toxic, irritant, & health hazard), and any other statutory requirement.

It is important to note that if the draft is approved, it will be an additional substance that requires BIS certifications. Currently, there are 52 chemical substances under compulsory BIS certification, this includes the marking on the product’s packaging.

On the 16^th of January 2022, China’s Ministry of Emergency Management (MEM) launched a new online platform for the registration of hazardous chemicals. The previous system launched in 2020 was closed on January 28, after which the new Hazardous Chemicals Registration Comprehensive Service Platform became operational.

This new platform solves the fear foreign companies once had about over-sharing their confidential business information, as this site helps secure such information. The new platform is referred to as National Registration Centre for Chemicals (NRCC).

With the new system, foreign companies can decide to either appoint a domestic agent or entrust the process to a third party so that confidentiality can be achieved. Before now, the only available option was the appointment of an agent which companies were wary of disclosing sensitive information to them.

Furthermore, Bryan Zhou says the foreign companies can meet registration obligations by working with the local importers of their substance. They can also appoint these local importers as their agents in China.

Therefore, there are lots of options that come with the new online platform. However, all options still require disclosure of information, some less than others. 

The Ministry of Environment and Ecology of China (MEE) published a Draft Plan for Digital Transformation in Hazardous Waste Management on the 18^th of January 2022.

This draft mainly focuses on the following aspects:

1.     Digital transformation in hazardous waste environment management

It mainly includes the implementation of the electronic management ledger of hazardous waste, the unified management of the transfer of hazardous waste, the implementation of a paperless operation of the inter-provincial transfer of hazardous waste, the regulation of hazardous waste management reports, and the regulation of hazardous waste export approval.

2.     Improving the intelligent level of environmental supervision of hazardous waste

This aim requires adapting to a new supervision mode on hazardous waste via the Internet of Things (IoT). This includes the construction of an online trading platform for hazardous waste and the pilot of third-party payment, and the deepening of the pilot work of collecting and transferring waste lead-acid batteries.

3.     Strengthen the docking and application of a national information system

This notification focuses on further strengthening the docking and application of a national information system that can clarify the relevant requirements for data docking, reporting, and application.

For further information, please email compliance@gpcregulatory.cn or message the WeChat account of 0708381983 (GPC China).

Updated Enforcement Rule of The Consumer Chemical Products and Biocides Safety Control Act (K-BPR) came into effect on December 31st, 2021.

This updated Enforcement Rule reflects matters mandated by the ‘Belief System for Biocidal Product Victims’ in K-BPR. ‘Belief System for Biocidal Product Victims’ is a system to pay relief promptly to biocidal product victims with health damage, and to impose and collect contributions on responsible manufacturers and importers of such biocidal products.

The major updates are as follows:

• Composition and operation of a biocidal product damage investigation team
• Details of requested data
•  Establishment of effective period for decision to pay relief
• Operation of the relief account, and composition and operation of the relief account management committee
• Procedures for imposing and collecting contributions for biocidal product victims, etc

The Ministry of Environment (MoE) in South Korea is consulting on a draft amendment of Designation of Substances Subject to Intensive Control under Enforcement Decree of the Act on Registration and Evaluation of Chemicals (K-REACH), which was published on Jan. 28th, 2022.

The draft amendment mainly proposes revisions including:

• Designating 54 types of substances (162 in detailed list) that have been confirmed harmful in the criteria of endocrine system disorders, persistence/bioaccumulation/toxicity, and high persistence/ high bioaccumulation by foreign governments or international organizations
• Deleting 4 types of substances that are Prohibited Substance
• Combining current Appendix 1 and Appendix 2, and grouping substances with similar or identical structures or functional group with specific list under the group

If you have any opinion on this amendment, please write your opinion and submit to the MoE by post.

The deadline of this consultation is Feb 17th, 2022.

National Institute of Environmental Research (NIER) in South Korea updated and announced the results of hazard review of chemical substances under K-REACH on February 11th, 2022.

The updates are as follows:

·         Update the hazard information of substances with the unique no. “2020-032”, “2020-034”, “2020-041” and “2020-050”

·         Create the hazard information of substances with the unique no. from “2022-170” to “2022-199”

This update came into effect immediately.

The Ministry of Health, Labour and Welfare (MHLW) in Japan recently designated 4-methylbenzenesulfonic acid as a deleterious substance. This is an industrial substance widely used in coating products, polymers, lubricants, and greases. Most importantly, this restriction starts from April 30.

For manufacturers, importers, and end-users of this substance, you must notify the ministry. This notification also applies to preparations that contain about 5% of the substance. Starting from the application date, notification will also be subjected to the requirements of the Poisonous and Deleterious Substances Control Act, as relevant to the substance notification. 

These requirements include:

· business registration by manufacturers, importers, and sellers,

· appointment of qualified personnel to prevent health and hygiene hazards,

· labelling on substance packaging and containers,

· provision of a safety data sheet (SDS), 

· record keeping, and

· sound disposal management.

Last  Update: 2022-02-08

On January 12, 2022, the Brazilian government issued a Regulatory Decree for the National Waste Policy, officialized and published by Law 12.305 on August 2010. The Regulatory Decree 10.936 does not repeal the existing version; instead, it ratifies and details the legislation's applicability.

The new Decree has an embracing scope whereby manufacturers, importers, distributors, traders, and consumers must observe the correctly packaging, segregation, and final destination of generated residues. It includes, for example, a segregation collection system and the reverse logistics plan.

Another important aspect is the inclusion of collectors’ cooperatives and associations of reusable and recyclable materials, which play a relevant role throughout the national territory. Finally, the National Registry of Hazard Operators and the National Information System for Waste Management is created to keep records, collect information, publish reports, and track performance goals.

It is recommended that all interested parties scrutinize the new Decree to ensure a safe and proper operation.

Last Update: 2022-02-11

On the 13^th of February, Switzerland had a vote to decide if full animal testing should be banned or not. This includes animal testing for both scientific and medical research.

If voted for, the ban would include:

·       a ban on the importation of products created through animal testing,

· a ban on human experiments, and 

· A certainty that non-animal testing will receive a level of support from the state that is almost the same as the support provided for animal experiments’ research.

During the voting process, 21% of the participants voted in favour while 79% voted against. Otherwise, Switzerland would have become the first country to fully ban animal testing. In 2017, Switzerland banned cosmetics that contain ingredients tested on animals.

However, Julia Baines from PETA UK said the rejection of the full ban does not equal approval of animal testing as this is collectively aimed at human clinical trials as well as the manufacturing, export and import of products tested on animals.

On January 25, 2022, the Organisation for Economic Co-operation and Development (OECD) decided to open a discussion to evaluate the membership of Argentina, Brazil, Bulgaria, Croatia, Peru, and Romania in the organization. The initiative highlights the progress made by the six countries since their first respective requests for OECD membership.

Before the start of the assessment, countries must confirm the adherence of OECD's values and guidelines governed by the 60^th Anniversary Vision Statement and the Ministerial Council Statement, which all members adopt by consensus. The Secretary-General has sent letters addressed to the heads of state of those candidate countries for this purpose.

The evaluation process includes more than 20 technical committees that will examine the candidates' legislation, policy, and practices. OECD will support the countries' advancement elaborating individual roadmaps according to the reality of each nation for the best alignment with the organization's framework.

In Latin America, the OECD plays a crucial role in developing each country's chemical regulations. Chile and Colombia (recently joined the OECD) are the only countries in the region that have adopted a comprehensive chemical regulation. Mexico and Costa Rica (also OECD members) are still developing such guidelines. Argentina, Brazil, and Peru are seeking adhesion and have already started elaborating on national chemical instruments to leverage the chances of acceptance.

Check below the condition for each country.

The Norwegian Environmental Agency announced on February 3, 2022, that the duty to declare annual quantities for 2021 is postponed until May 20, 2022. This occurred because the agency is improving the Product Register – the portal for chemical declaration in Norway. 

According to the Norwegian Chemical Declaration Regulation, the duty falls on manufacturers or importers dealing with hazardous chemicals (according to CLP regulation) of 100 kg or more, biocides, chemicals containing microbiological products, explosive precursors, and substances which experienced changes to label or commercial name.

The new portal is expected to be ready by March 15-31, 2022, where the industry will be able to access the portal with the new application already functioning.

Last Update: 2022-02-14

On January 21, 2022, Chile published the determination decision to start the elaboration of a decree to regulate the instrument intended to prevent waste generation and promote waste recovery.

The future Decree will focus on household products, especially food, personal hygiene, and cleaning products. The labeling of the articles above must display the information on the components, composition, and instructions for recycling.

It also foresees the creation of a voluntary certification program for household packing when meeting specific recyclability criteria. The Decree will be closely related to Decree 12/2020, responsible for setting Chile's packing collection and recovery goals.

To obtain the recyclability seal, manufacturers must observe:

• that at least 80% of the weight of the container is made of technically recyclable materials;
• that the materials can be separated from the rest of the container; and
•       that there is currently demand from the recycling industry for these materials.