GPC Newsletter Aug-2022

The European Commission opened, on 5 August 2022, a consultation on the safety requirements to be met by standards applying to several categories of children products. 

The draft Commission Decision is adopted under the framework set up in Directive 2001/95/EC, known as the General Product Safety Directive. Under the Directive, the Commission can establish safety requirements to be met by product standards, which then must be incorporated into the standards adopted by European standardization bodies. 

The Commission proposal would establish safety requirements for standards concerning: 

• Products intended to be worn by children
• Products intended to facilitate seating, sleeping, bathing, body care, relaxation, transportation, and early learning 
• Products intended to facilitate feeding, drinking, or sucking 
• Products related to children’s products (accessories to the covered categories above, or products to be mounted or installed by adults which are accessible or offer protective functions to a child)

The safety standards address a broad range of hazards, such as chemical hazards, flammability hazards or hazards associated with the project’s parts. 

Despite the broad scope of the new standards, some product categories will not be covered by them. This is especially the case of toys, which are governed by their own piece of legislation (Directive 2009/48/EC, the Toy Safety Directive). The provisions of the General Product Safety Directive only apply to products to the extent that they are not covered by product-specific legislation. 

The Commission is also working on a revision of the Toy Safety Directive, for which public consultations concluded in May 2022.

Both the proposed standards for children’s products and the revision of the Toy Safety Directive are actions taken under the EU’s Chemicals Strategy for Sustainability, which applies the vision of the European Green Deal to the chemicals sector. You can learn more about the Chemicals Strategy for Sustainability by re-watching our recent webinar on the topic. 
 

The European Commission is extending an ongoing consultation by the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) on the presence of cobalt in toys until September 8, 2022. 

The consultation is part of an evaluation on the permissibility of the use of cobalt in toys under the provisions of Directive 2009/48/EC (the Toy Safety Directive). Under the Directive, CMR substances can not be used in toys unless: 

• Their concentration is below under the thresholds for classification, or
• There are inaccessible in any form when used as intended or in a foreseeable way, bearing in mind the behaviour of children, or
• A decision to authorize them for specific uses has been made under the Directive

The ongoing consultation refers to the third option. To take a decision to authorize the use of a CMR substance, three conditions are needed. 

• The substance must be found to be safe by a Scientific Committee (SCHEER in this case)
• There must be no suitable alternatives, and  
• The substances must not be prohibited for use in consumer articles under REACH 

Therefore, the analysis of SCHEER concerns the safety of the use of cobalt in toys, as well as the availability of alternatives. Interested stakeholders can submit their comments on SCHEER’s preliminary report, which finds that information available is insufficient, and recommends limits on the use of cobalt in products liable to inhalation. 

A similar consultation on a SCHEER opinion on the use of titanium dioxide in toys concluded on July 4, 2022. 

The push for safer toys and children’s products is part of the Chemicals Strategy for Sustainability. Consultations on the review of the Toy Safety Directive concluded on May 25, 2022, and adoption of the Commission’s proposal is expected before the end of the year. Additionally, consultations are ongoing for safety requirements in standards for children products under Directive 2001/95/EC (the General Product Safety Directive). 
 

In its recently held 60th session, the United Nations (UN) Sub-Committee of Experts on the Transport of Dangerous Goods adopted proposed amendments to the UN Model Regulations on the Transport of Dangerous Goods that would clarify the scope of test data sharing in the value chain. 

The Model Regulations are an effort by the UN to develop common approaches to the management of dangerous goods in transport. While not directly applicable, they seek to inform the development of national regulation. Under the Model Regulations, manufacturers and subsequent distributors have a duty to “make available” test summaries for lithium batteries or equipment containing them. 

The amendment proposal adopted by the Sub-Committee would add a note to the provision clarifying that the purpose of this requirement is to enable other actors in the supply chain to assess the compliance of the batteries. 

The Sub-Committee is a subsidiary body of the Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labeling of Chemicals. If the amendments are adopted, they would be incorporated into upcoming revisions of the Model Regulations. After that, it would fall upon national governments to incorporate changes in their legislation. 
 

Under the Chemical Strategy for Sustainability (CSS) plan (2020) the EU outlined a renewal of the UN Globally Harmonized System (GHS)chemical hazard classes for endocrine disruption and persistence.  

In the CSS strategy, the EU plans for the creation of new hazard classes for both GHS and the EU CLP Regulation. The EU has already started its work on the CLP proposal and it will be announced on the 26th of October. While the GHS formal proposal will come after – in December. There are several issues with this approach, however: 

1. The CLP system is based on GHS, therefore the more logical approach implies starting with a renewal of the GHS system rather than the CLP. 

2. The fact that the EU is working on a GHS proposal ahead of the UN, which is responsible for the GHS, creates confusion and threatens to disarray the international system. 

3. There is some scepticism on whether the new classes are needed since the current ones function well and how new hazard classes will regulate the animal-testing requirements in that case. 

All in all, it seems like the EU has taken the lead on the renewal of GHS for endocrine disruption and persistence classes, but we are yet to see how this will be applied in practice.  

On August 17, 2022, the UK’s Environment and Health Security Agencies released a report reviewing potential approaches to the management of risks arising from unintentional mixtures. While this is in keeping with the discussions on chemical management in the European Union, the Agencies’ findings point – if implemented – to the risk of regulatory divergence between the UK and the EU. 

The issue of unintended mixtures is one of the key points raised in the European Union’s Chemical Strategy for Sustainability, which outlines the framework for a far-reaching reform of the bloc’s chemical legislation framework. In the context of the ongoing revision of Regulation (EC) 1907/2006 (the REACH Regulation) in the European Union (EU), the introduction of a Mixtures Assessment Factor (MAF) when conducting substance risk assessments has been proposed. 

Now, the report released by the two UK Agencies proposes the partial use of MAF when conducting risk assessments. However, it proposes limiting it to environmental risk assessment in aquatic media. Therefore, other media and human health risk assessment would not include this approach to tackling unintentional mixtures. 

Changes requiring businesses to include a MAF would need to be implemented in the UK through specific reform of UK REACH. In the EU, the Commission’s formal proposal to amend REACH is still in the works, and has not been officially presented yet. Therefore, the potential for divergence on this topic across both regulatory regimes will be clarified in the future. 
 

On June 26th 2022, the Ministry of Environment, Urbanisation, and Climate Change, Turkey announced an update for the KKDIK registration regarding the languages of the reports to be submitted.

Importers or manufacturers residing in Turkey and Only Representatives residing in Turkey appointed by manufacturers residing outside of Turkey should submit the technical dossier including the main information for the substances above 1 TPA.

In the announcement, the Ministry indicated that Full Study Reports and other attachment documents can be uploaded in English to the Chemical Registration System. However, other fields in the system such as "Robust Study Summaries" and "Study Summaries," remain to be Turkish only.

The deadline for final registration under KKDIK is 31st December 2023. Substances not registered after 31st December 2023 will not be able to enter the Turkish market.

On July 27, 2022, the Central Government of India announced the deadline for four chemical substances regulated by the Bureau of Indian Standards (BIS) Act (2016) will be posted. The chemicals and their new deadlines are:

1. Morpholine: February 1, 2023
2. Acetic Acid: February 3, 2023
3. Methanol: February 3, 2023
4. Aniline: February 3, 2023.

After the deadlines, manufacturers would need to apply for BIS certificates before importing activities.

To learn more about your obligations on chemicals under the BIS certification, read more here  

To know the chemicals that are under BIS scheme, click here 

In July 2022, the Indian Ministry of Chemicals and Fertilizers signed a Memorandum of Understanding with the International Labour Organization (ILO) in order to adapt the International Chemical Safety Cards (ICSC) used for information dissemination to Chemical Industry. 

The ICSC is developed by the World Health Organization (WHO) and the International Labour Organization in cooperation with the European Commission to promote occupational safety and health on sites and among workers. The ICSC consist of special data sheets intended to provide concise information on chemicals regarding their safety and health impacts. The benefits of the ICSC are that they can be easily used to distribute information on hazardous properties of chemicals in an understandable and precise way. Furthermore, the information on chemicals in the cards is frequently updated to always provide the latest information. The ICSC includes the Globally Harmonized System of Classification and Labelling (GHS). Currently, on the website of the Department of Chemicals and Petrochemicals,  

1784 ICSC cards are available,  https://chemicals.nic.in/international-chemical-safety-cards-database   

The Industry of the Association of Chemicals and Petrochemicals in India has been requested, to start the use of the ICSC at working sites. 

On August 19, 2022, National Medical Products Administration of China (NMPA) published a notification announcing that cosmetic digital certificate will be formally implemented. This notification was made based on the rules of ‘Digital Signature Law of China’ and ‘Measures for the Administration of Electronic Certificates of National Integrated Online Government Service Platforms’. 

This notification requires that from October 1, 2022, 

• For special cometic products and cosmetic new ingredients which are registered under Measures for Cosmetic Registration and Notification (part of CSAR, Cosmetic Supervision and Administration Rules) and those certificates which are extended and changed under Measures for Cosmetic Registration and Notification, digital certificates will be granted. Paper-based certificates which were granted before, it will be valid within the validation period. But it won’t be renewed. 
• For special cosmetic products certificate which are allowed to change under Measures for Cosmetic Registration and Notification, the registrants shall return the paper-based certificates to NMPA according to CSAR requirements. 

Additionally, this notification specifies the way and place for picking up the digital certificates. Once the digital certificates are prepared, it will be uploaded to the registrants’ NMPA accounts. Registrants can pick up it by log into NMPA online service center. The digital certificates can be used in many forms, including certificate authorization, scan to check, online verification, online sharing etc. 

If you have any inquires relating to cosmetic products and ingredients registration and submission in China, please contact GPC China via compliance@gpcregulatory.cn or follow our WeChat account 46 0708381983.

To implement ‘New Pollutant Management Action Plan’, on July 20, MEE (Ministry of Environment and Ecology of China) published a notice regarding public comments on chemicals that should be assessed of environmental risks with priority. It seeks to collect suggestion and opinions from public for chemicals to be listed in the first band for prioritize environmental risk assessment of chemicals. 

The ‘New Pollutant Management Action Plan’ was released in May 2022. The aim of it is to assess the environmental and health hazard of chemicals, with a primary focus on substances produced or used in large quantities, detected frequently in the environment, or used for various purposes, while developing an assessment database. Within this Action Plan, it outlined a plan to assess important chemicals which will be formulated and prioritized for environmental risk assessment. As a result of the plan, the notice was published to circulate public opinions. The estimate deadline for compiling these substances is the end of 2022. 

According to the requirements mentioned in this notice, proposed chemicals must meet the requirements of the guidelines for screening of priority assessment chemical substances (HJ 1229-2021). Meanwhile, this notice also enclosed an attached form which is Chemical Substance basic information list. Proposed chemicals need to include the following information: 

• Chemical name in Chinese and English
• CAS 
• Eco-toxic features and health toxic features 
• PBT characters 
• Hazardous classification 
• Use history in China and overseas 
• Risk and risk control measures 
• Others 

If you have any inquiry relating to China REACH, please contact us via compliance@gpcregulatory.cn. 

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘the results of hazard review of chemical substances’ under the Act on Registration and Evaluation of Chemicals (K-REACH).

The draft amendment mainly proposes revisions including:

• Notification of the results of hazard review of registered chemical substances
  • Addition of 52 new substances from “2022-172” to “2022-223”
• Revision of 37 notified new substances by adding additional information
• Notification of information on classified substances: the name of chemical substances, CAS no., toxic substance designation, main hazard, classification and labeling, etc

If you have any opinion on this amendment, please write your opinion and submit it to the NIER.

The deadline for this consultation is Aug 11th, 2022.

The Ministry of Environment (MoE) in South Korea updates the Enforcement Rules of the Act on Registration and Evaluation of Chemicals (K-REACH).

The main updates include:

• Requirement on hazard reviews including hazards, use, exposure and etc to designate substances subject to permission
• Omission on the Environmental hazard data for registration if water solubility is less than 1㎎/ℓ, or if the use is intermediate or process regulators
• Simplification on report exemption requirements for new chemical substances to be imported less than 0.1 tpa for research and development use

The amendment came into effect immediately.

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘Regulation on preparation methods for registration application dossier and hazard review methods’ under the Act on Registration and Evaluation of Chemicals (K-REACH) on August 25th, 2022.

This is to minimize the use of vertebrates for the chemical registration and hazard review by regulating hazard review method to use non-test data.

The main updates include:

• Addition of hazard view method based on non-test data definition and type (QSAR, correlation method, evidence method, etc.)
• Addition and specification of exemption conditions for each test category based on chemical substance properties or non-test data
• Addition of methods to submit opinions to the president of the NIER if a person who received the result of hazard review disagrees with it

If you have any opinion on this amendment, please write your opinion and submit it to the NIER.

The deadline for this consultation is Sep 14th, 2022.

South Korea enacts the ‘Regulation on Labeling and Advertising of Consumer Chemical Products’ under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR) on July 28th, 2022. This Regulation is to regulate phrases or expressions that manufacturers, importers, sellers or distributors of the consumer chemical products and biocides should not use when packaging or advertising the product. The regulation includes specific phrases restricted for labelling and advertising.

The main phrases restricted for labelling and advertising include:

•   Phrases that can be misunderstood as non-toxic
  • Example: Non-toxic, Toxic-zero
• Phrases that can be misunderstood as having no negative impact on environment and nature
  • Example: natural (exception: if the content is 100% natural), green, eco, care about environment, naturalism, pure, etc
• Phrases that can be misunderstood as having no harm and may lead to excessive use or incorrect use of the product
  • Example: no impact on human health, safe, no harmful substances, good, safe for children, etc
• Phrases that can be misunderstood as having no negative impact on human or animal
  • Example: well-being, care about human health, etc

This regulation will be reviewed and may be updated every three years.

This comes into effect from July 29th, 2023.

The National Institute of Environmental Research (NIER) in South Korea updates ‘the results of hazard review of chemical substances’ under the Act on Registration and Evaluation of Chemicals (K-REACH). This update is mainly on new substances.

The main updates on new substances are as follows:

1) Updates on chemical substance name, etc: “2019-144", “2019-178", “2019-179", “2020-203" and “2022-21"

2) Updates on hazard information, etc: “2016-32", “2016-210", “2016-337", “2016-498", “2016-877", “2016-1126", “2017-33", “2017-286", “2017-311", “2017-414", “2017-548", “2017-589", “2017-812", “2018-523", “2018-699", “2019-148", “2019-200", “2019-257", “2019-315", “2019-452", “2019-466", “2019-821", “2020-47", “2020-230", “2021-26", “2021-27", “2021-38", “2021-78", “2021-84", “2021-178", “2022-102" and “2022-114"

2) Addition of 52 substances and their hazard information: from "2022-172" to "2022-223"

The amendment came into effect immediately.

Taiwan’s EPA plans to modify the “Regulations for the Labelling and Materials Safety Date Sheets for Toxic and Concerned Chemical Substances” and is consulting until 20 August. This modification is to harmonize with EU’s Regulation on the classification, labelling and packaging (CLP) and to ensure the information of the labelling for toxic and concerned chemicals is clearly conveyed.

The current labelling is consisted of pictogram and content. On the content, it includes name, hazardous ingredients, cautious and warning words, hazard statement, precautionary statements, manufactures/suppliers’ information (e.g., name, address, telephone number).

According to the draft amendment published on July 21, key modifications are:

• Adding containers and packaging’ smallest size requirement. Manufacturers may use fordable labels or attached to the containers if the surfaces or materials of the containers are limited. 
• For toxic and concerned chemicals substances, if the hazardous characteristics cannot be classified in accordance with the classification schemed in the National Standard CNS 15030, manufacturers are allowed to only label name, hazardous ingredients and manufacturer/suppliers’ info.
• For package under 100 ml, it only needs to label name, pictogram and cautious and warning words.
• The government may issue specific wording to certain chemicals that are under control. For instance, in order to manage the use of Nitrous oxide (laughing gas), the government may ask manufacturers to include “restricted for industrial use, prohibited for recreational use”  

After the modification, Taiwanese government will give manufacturers one-year grace period to adopt to the new labelling requirements, which as the EPA stated is 31 August 2023.  

This modification can help industries to prepare the labelling more consistent with both export and import requirements. For package/container under 100 ml, the label requirements are reduced.

The registered importer or manufacturer who introduced the chemicals during the previous registration year must submit the annual declaration under AICIS. The submission starts from August 1 and ends on November 30, 2022. This applies to all chemical introductions, regardless of the category, the amount, or the number of chemicals. The annual declaration covers activities from 1 September 2021 to 31 August 31, 2022.

The annual declaration should include:

• the introduction categories for the chemicals you imported or manufactured during our registration year
• a declaration that all of your introductions were authorised under sections 25 to 30 of the Commonwealth's Industrial Chemicals Act 2019.

GPC can help you for the Annual Declaration.  

According to the Australian authorities, a separate post-introduction declaration is needed for chemicals defined as “exempted” submitted during 2021- 2022. Declarations for exempted chemicals should cover the period of 1^st September 2021-31^st August 2022 and can be submitted from 1^st August until 30^th November 2022.

A separate submission should be done for each exempted chemical, the total number of PLCs and the total number of low-concern biopolymers.

Note: post-introduction declaration presumes that an introduction for exempted chemicals has already been done. This concerns:

• polymers of low concern (PLCs)
• low-concern biopolymers
• chemicals categorised as very low risk for human health and the environment

GPC can always help you with your submission!