GPC Newsletter Feb-2023

A comprehensive plan that outlines more than 150 steps to assist business and government agencies in achieving the Green Deal and digital targets by 2050 has been released by the European Commission in collaboration with stakeholders. The main elements of the EU Green Deal are: Climate action, Clean energy, Sustainable industry, Buildings and renovations, Sustainable mobility, Eliminating pollution, Farm to Fork, Preserving biodiversity, Research and development as well as Preventing unfair competition from carbon leakage. 

In order to support the Union's transition to a "toxic free" environment, climate neutrality, circular economy, and digitalization, the "Transition Pathway for the Chemical Industry" document, which was published on 27 January 2023, proposes steps, including safe and sustainable by design (SSbD) measures and substitution to safer substances. 

Sustainable competitiveness is one of its 2050 "building blocks." Developing, commercialising, deploying, and encouraging the use of SSbD substances and materials are some of the proposals made to achieve this. Other suggestions include making sure that dangerous chemicals that are prohibited in the EU are not produced for export, by amending applicable legislation as needed. 

A list of actions that stakeholders may do to encourage the transition to safer chemicals is also included in the document. As part of the new circular economy action plan, one phase is to adopt and enforce the Ecodesign for Sustainable Products Regulation (ESPR). To guarantee that consumer items don't include chemicals that cause cancer, gene mutations, disrupt the reproductive or endocrine systems, or are persistent, bioaccumulative, and hazardous, authorities should take action to expand the general approach to risk management. This suggests a new digital infrastructure where parties could share high quality data on chemical hazard profiles and the environmental impact of products. They could extend this to other chemicals, including those toxic to particular organs and those affecting the immune, neurological, or respiratory systems.

The European Chemicals Agency (ECHA) has released the full details of a proposed EU REACH restriction that aims to limit the use of more than 10,000 per- and polyfluoroalkyl substances (PFASs), which are commonly known as "forever chemicals." The proposal has been authored by the authorities of five European countries - Denmark, Germany, the Netherlands, Norway, and Sweden - and outlines two options for restricting the use and placement on the market of these substances, which are concerning due to their persistence, bioaccumulation, and toxicity.

The first option involves a complete ban of PFAS with no exemptions and a transition period of 18 months after the regulation takes effect. Option two is a complete ban with specific, time-limited exemptions for certain uses, such as active substances in plant protection and biocidal products, as well as human and veterinary medicinal products. This option also carries an 18-month transition period and a 5 or 12-year exemption period, depending on the application. The authors of the restriction propose a ban on consumer products after 18 months, a 5-year exemption period for products where alternatives are being developed, and a 12-year exemption period for products where no alternatives exist at the moment.

The restriction report considers option two to be the most balanced approach, allowing time for alternatives to be developed while still promoting the phase-out of PFASs. The proposal is the broadest restriction of PFASs ever submitted, covering at least 10,000 of these substances.

The restrictions will not result in a total ban on PFASs in other substances, mixtures, or articles but will set limits for their use.

The next steps for the proposal include legal checks by ECHA's committees for socio-economic analysis and risk assessment, followed by a six-month consultation and adoption by the European Commission. The restriction is expected to be adopted and enter into force in 2025 and become applicable in 2026-2027.

The background:

In the EU, around 230,000 tonnes of PFASs are placed on the market each year, used in various sectors including textiles, food packaging, electronics, construction, and medical devices. Recently risks related to the manufacturing, placement, and use of PFASs has been identified. Thus a proposal to restrict per- and polyfluoroalkyl substances (PFASs) under the European Union's chemicals regulation, REACH, has been submitted to the European Chemicals Agency (ECHA) by the national authorities of Denmark, Germany, the Netherlands, Norway, and Sweden in January.

In relation to the EU's RoHS Directive, the European Commission stated on January 16, 2023, that it is looking for comments from interested parties on a request for an exemption for lead in polyvinyl chloride (PVC). The specific exemption requested relates to lead in PVC, which is utilised as a base material in sensors, which are used in in-vitro diagnostic medical equipment. 

The Member States are required by Directive 2011/65/EU on the restriction of the use of certain hazardous chemicals in Electrical and Electronic Equipment (EEE) to assure that EEE put on the market does not include the hazardous compounds listed in Annex II to that Directive.  

Of the 10 compounds that are now listed, lead is one that is considered to be hazardous. The remaining ones are bis (2 ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), diisobutyl phthalate, cadmium, hexavalent chromium, mercury, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), and polybrominated biphenyl (DIBP). The materials and electronic equipment parts that are exempt from the substance limits are listed in the Directive's Annexes III and IV for possible purposes. 

It has been shown that lead is a poisonous toxin that harms the neurological system's growth, causes chronic kidney illness, and raises blood pressure. In PVC, the foundation material for sensor cards, lead is used as a thermal stabiliser. These cards are a component of disposable cartridges used in diagnostic medical analyzers that may enable precise measurement of certain analytes on a single entire blood sample, such as sodium, chloride, glucose, pH value, etc. Near the point of care, the medical analyzers are utilised to get blood results quickly (e.g., in emergency departments). Such uses were covered by an earlier exemption in Annex IV of the RoHS Directive. 

The Commission has started a feedback drive about the proposed legislative act that would grant the proposed exemption. The review period closes on February 13, 2023. 

The UK Department for Environment, Food and Rural Affairs will publish its chemicals strategy later this year (no date announced). The UK's chemicals strategy is intended to replace the EU's REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) regulation, which the UK no longer has access to as a result of Brexit. 

The strategy will set out a risk-based approach to regulation diverging from the hazard-based approach taken by the EU. This means that the strategy will focus on managing priority and emerging chemicals of concern, including per- and polyfluorinated substances (PFASs), endocrine-disrupting chemicals (EDCs) and combination effects of different substances. In addition to managing priority and emerging chemicals of concern, the strategy will also focus on improving the department's understanding of the uses and exposures of chemicals across the UK. 

 The strategy will also map out a new UK REACH alternative transitional registration model and improve understanding of chemicals in the environment by continuing to develop monitoring methods. The strategy will utilize the department's prioritization and early warning system to inform decision-making and regulatory activities.

The Ministry of Environment, Urbanization, and Climate Change have launched a plan with the aim of eliminating the usage of HCBD in Turkey and getting the necessary support from the private sector to fulfill the obligations regarding the management of Persistent Organic Pollutants under the Stockholm Convention. The Global Environmental Facility (GEF) is funding this three-year project, which will expire in August 2024. UNIDO, the UN industrial development organization, is responsible for carrying it out.

The Ministry emphasized that this project has a very wide network of stakeholders and partners, and this is due to the very wide impact area of ​​Persistent Organic Pollutants.

Hexabromocyclododecane (HBCD) is a brominated flame retardant that applies extruded (XPS) and expanded (EPS) polystyrene foam mostly used as thermal insulation in the building industry. With this project, the Ministry is planning to phase out this chemical. The intention is to gradually replace HBCD with eco-friendly substitutes while also enhancing institutional, regulatory, and technical ability to carry out this transition successfully and sustainably.

On 2nd February 2023, the Ministry of Environment, Urbanization, and Climate Change of Turkey announced a new regulation related to KKDIK registration dossiers for sections 1.7 and 13.1. 

Firstly, the Turkish importers of the foreign company they represent must be listed in the "1.7 Suppliers" section of the registration dossiers. It has been determined acceptable to remove this supplier section information requirement from being an obligation after the Ministry evaluated the views and recommendations from industry associations, associations, and various organizations. In this case, even though it is advised that only representatives submit this information to the registration dossiers, not doing so will not affect the completeness check on the registration dossiers from the Ministry. However, the Ministry advises that only representatives need to keep track of the importer details in case they require them in the future. The content in the already published guides, such as "Registration Guide," "KKS User Guide," and the "Frequently Asked Questions" section in the Chemicals Help Desk, will be updated as soon as practical in this respect by the Ministry.

Secondly, section 13.1 on KKS includes Chemical Safety Reports for the registered substances. According to the Ministry, the Chemical Safety Reports, which must be included in registration files for chemicals weighing 10 tons or more annually, could cause additional costs because of the lengthy translation process, and the deadline of the registration period. In this context, as the registration deadline of December 31, 2023, is approaching, registrants could upload Chemical Safety Reports in English until then. However, registrants who prefer to upload the Chemical Safety Report in English are required to attach the translated version to the registration dossier in order to include the uses, exposure scenarios, and risk management measures in Turkey within 1 (one) year at the latest. In other words, even though English reports are accepted this year, from next year onwards Turkish reports should be prepared and included.

The deadline for KKDIK registration, 31 December 2023, is not expected to be postponed. We suggest that industry representatives should complete the process as soon as possible since substances not registered after the deadline will not be able to enter the Turkish market.

• Make an export notification before export and provide the information in Annex-3 to the Ministry for notification for chemicals in Annex-1 of the Regulation,
• Provide information about the annual amount of chemicals in Annex-1 and Annex-2 of the Regulation and the name and address of the importer to the Ministry,
• Provide a Safety Data Sheet in the official language or languages ​​of the imported country to the importing party together with the chemicals exported within the scope of this regulation,
• Export the chemicals within the scope of this regulation in a packaged and labeled form in accordance with the Regulation on Classification, Labeling, and Packaging of Substances and Mixtures,
• Ensure the transfer of information through the Ministry’s e-ÖBK system and comply with the rules determined by the ministry,
• Do not export the chemicals in Annex-6 of the Regulation,
• Provide additional information requested by the Ministry,

In January 2023 the government of India formally approved theNational Green Hydrogen Mission, with a stated aim of making India a global hub for the production of green hydrogen. 

The Mission will result in the following likely outcomes by 2030: 

• Development of green hydrogen production capacity of at least 5 MMT (Million Metric Tonnes) per year with an associated renewable energy capacity addition of about 125 GW in the country 

• Over 100 billion US dollars in total investments 

• Creation of over 600.000 jobs 

• Cumulative reduction in fossil fuel imports over 12 billion US Dollars Abatement of nearly 50 MMT of annual greenhouse gas emissions 

This mission will have wide ranging benefits: 

• Creation of export opportunities for Green Hydrogen and its derivatives 

• Decarbonisation of industrial, mobility and energy sectors 

• Reduction in dependence on imported fossil fuels and feedstock 

• Development of indigenous manufacturing capabilities 

•  Creation of employment opportunities 

• Development of cutting-edge technologies 

All concerned Ministries, Departments, agencies, and institutions of the Central and State Governments will undertake focused and coordinated steps to ensure successful achievement of the Mission objectives.  The Ministry of New & Renewable Energy will be responsible for overall coordination and implementation of the Mission. 

The Centre's National Hydrogen Mission emphasizes on generating hydrogen from green power sources. It focuses on developing India as a global hub for the manufacturing of hydrogen and fuel cell technology across the value chain. 

In a press release issued in March 2022, the government said, "The mission would put forward specific strategy for the short term (four years), and broad strokes principles for long term (10 years and beyond)." 

The Central Government of India has extended the enforcement date for 10 substances under the Quality Control Order (QCO). The amended enforcement dates were published in the Indian Gazette on 2 February 2023. The Quality Control Order is the regulation that requires concerned substances to carry the certification mark of the Bureau of Indian Standards (BIS). The 10 substances and their initial and new enforcement dates are listed in the table below.

On 18^th Jan. 2023, National Medical Products Administration of China (NMPA) published a notification on simplifying normal cosmetic products tests requirement for record filling procedure. This notification measure is enforced from the date of publication. 

According to the notification, those normal cosmetic products which adopt inspection as quality control measures and the production process has been included in the daily supervision of Provincial Medical Products Departments, the inspection report issued by the cosmetics filing party or the entrusted manufacturer that conducts self-inspection in accordance with the relevant requirements of the cosmetics technical specification can be submitted. Except for one of the following situations: 

• The product claims to be used by infants and children.
• The product uses new cosmetic raw materials that are still under safety monitoring.
• The product claims to have effects such as acne removal, nourishment, repair, anti-wrinkle, dandruff removal, and deodorization.
• Other situations where the product may have relatively high safety risks.

When submitting a self-inspection report when the product is filed, the filing party should also submit a statement of the corresponding inspection capabilities for the cosmetics filing inspection stipulated in the "Cosmetics Registration and Filing Inspection Work Specification", and provide the corresponding inspection personnel, equipment, facilities, and site environment for self-inspection.

For more China REACH and cosmetic compliance information, please contact GPC via compliance@gpcregulatory.cn.

The Ministry of Food and Drug Safety (MFDS) in South Korea updates the Regulations on Safety Standards for Cosmetics under the Cosmetic Act on Feb 21^st, 2023. This is to strengthen safety management of cosmetics and protect public health by designating raw materials that cannot be used in cosmetics, considering the results of risk assessment and overseas regulatory trends.

The main updates are as follow:

Change some of hair dye ingredients from the restricted list of cosmetics to the prohibited list of cosmetics.

• Add O-aminophenol, M-phenylenediamine, and Hydrochloric acid M-phenylenediamine to the prohibited list
• Change from Catechol (Pyrocatechol) (exception for a hair dye component of a mixture based on to the usage or capacity of oxidation hair dye, below 1.5%) to Catechol (Pyrocatechol)
• Change from Pyrogallol (exception for a hair dye component of a mixture based on to the usage or capacity of hair dye, below 2%) to Pyrogallol
• Update hair dye ingredient in Annex 2

The amendment came into effect in 6 months from the published date.

The National Institute of Environmental Research (NIER) in South Korea publishes the Guidelines for the Approval of Natural Biocidal Compounds in December 2022. In accordance with the enforcement of the Consumer Chemical Products and Biocides Safety Control Act (K-BPR), biocidal substances or products manufactured or imported to South Korea should get approval before its sales or release in Korean market. This guideline explains data preparation method and data requirement for the approval of natural biocidal compounds, regarding the comprehensive safety data under the Regulation on the Scope and Preparation Methods for the Approval of Biocidal Substances and Products.

This guideline has two chapters as below:

Chapter 1. Approval of biocidal substances and products: Regulation on the approval of biocidal substances, approval process, data requirement

Chapter 2. Application for the approval of polymer compounds: Information on natural biocidal compounds, considerations when applying for the approval of natural biocidal compounds, requirements for application for approval of natural biocidal compounds

If you are planning to apply for the approval of natural biocidal compounds, please refer to the guideline for the details.

The National Institute of Environmental Research (NIER) in South Korea publishes the Guidelines for the Approval of Biocidal Polymers in December 2022. In accordance with the enforcement of the Consumer Chemical Products and Biocides Safety Control Act (K-BPR), biocidal substances or products manufactured or imported to South Korea should get approval before its sales or release in Korean market. This guideline explains data preparation method and data requirement for the approval of biocidal polymers, regarding the comprehensive safety data under the Regulation on the Scope and Preparation Methods for the Approval of Biocidal Substances and Products.

This guideline has two chapters as below:

Chapter 1. Approval of biocidal substances and products: Regulation on the approval of biocidal substances, approval process, data requirement

Chapter 2. Application for the approval of polymer compounds: Information on polymer compounds, considerations when applying for the approval of polymer compounds, requirements for application for approval of polymer compounds

If you are planning to apply for the approval of biocidal polymers, please refer to the guideline for the details.

The Ministry of Environment (MoE) in South Korea extends the deadline for the public consultation on the draft list of substances subject to permission under the Act on Registration and Evaluation of Chemicals (K-REACH). The MOE published 11 potential substances subject to permission on Novebmer 23^rd, 2022.

These substances subject to permission are:

Additionally, they are going to publish hazard information and other relevant data on December 12^th, 2022. This would include 1) hazard information, 2) main use and exposure information, 3) distribution volume in Korea, 4) types of people who may be exposed in the process of handling chemicals and etc.

If you have any opinion on this draft, please write your opinion and submit it via www.chemnavi.or.kr.

The deadline for the public consultation opens is Feb 28^th, 2023.

In 2013 voluntary national standard, CNS 15663 Guidance to Reduce the Use of Restricted Chemical Substances in Electrical and Electronic Equipment (EEE), was released by the Taiwanese Bureau of Standard, Metrology and Inspection (BSMI). The standard outlines the EEE items covered, the concentration limits for 6 hazardous compounds, and the marking procedures for the presence of hazardous substances in EEE products. It is frequently referred to as Taiwan RoHS since the standard is extremely similar to the RoHS regulations in China and the EU. 

On December 23, 2022, the BSMI of Taiwan published regulations, requiring inspection of electrical UV disinfection equipment. The rules went into effect straightaway, and imported and domestically produced goods will be subject to inspection beginning May 1, 2023. These regulations contain Taiwan RoHS, also known as Section 5 "Marking of Presence" of the CNS 15663 (2013) standard. This indicates that Taiwan RoHS governs UV disinfection electrical equipment. 

Requirements:  

• Manufacturers and importers must require Registration of Product Certificate (RPC). 

• The items must comply with the CNS 15050 testing standard for controlled substances and have the BSMI mark and RoHS label on their packaging. 

• The Medical Device Management Act defines UV disinfection equipment as medical devices, therefore they are exempt from the new regulations. 

Lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBBs), and polybrominated diphenyl ethers (PBDEs) are among the substances that have concentration limitations enforced, according to the CNS 15663 Guidance on Reducing Restricted Chemicals in Electrical and Electronic Equipment (EEE).  

Japan’s Ministry of Health, Labour and Welfare (MHLW) has classified 200 substances under Category 1 for carcinogenicity. The announcement was made on 26 December 2022, under an amendment to the Industrial Safety and Health Act (ISHA).

Companies handling these compounds are required to adhere to ISHA regulations, which include maintaining records of the safety precautions implemented as a consequence of risk assessment and the level of worker exposure for 30 years.

The mandatory requirement will be implemented in two phases.

Phase 1:

Enforcement will begin on 1 April 2023 for 120 substances which include:

• Biphenyl
• Tetrafluoroethylene
• 1,2,3-trichloropropane

Phase 2:

Enforcement will begin on 1 April 2024 for the remaining 80 substance which include-

• Lead styphnate
• Glycidamide
• Chloramphenicol

On 26 December 2022 the Brazilian National Health Surveillance Agency (ANVISA) published Resolution RDC 772/2022 which provides a new simplified procedure for the registration of personal hygiene products, cosmetics, and perfumes.  The resolution entered into force on 2 January 2023. The initiative aims to reduce the number of post-registration applications for personal hygiene products, cosmetics, and perfumes pending the ANVISA’s response. On its official website, ANVISA estimated that the impact of implementing the new measure would reduce the queue by up to 20%. 

The change represents the simplification of the ordinary procedure. This means that requests will automatically be approved when complying with Article 3 of RDC 772/2022.  

The aim of this new regulation is to bring legal certainty to ANVISA’s actions and favor the optimization of the analysis of requests with less risk to health. Additionally, it is logical to understand that access to regularized personal hygiene products, cosmetics, and perfumes in Brazil will be expanded, based on the principle of presenting all the technical and legal documentation required by ANVISA.  

Moreover, this regulation incorporates elements concerning confidentiality. Another important aspect is that this regulation also deals with the commitment, participation, and legal responsibility of the companies holding registries in the country, establishing the corresponding sanctions in case of non-compliance with the norm. 

Article 3 of the new RDC establishes post-registration requests subject to the simplified procedure. These are changes in labelling, registration cancellation, registration petition withdrawal, presentation of the registered product, manufacturer indication, modification of the formula, manufacturer change, tone name change, reduction of the validity term, replacement of the presentation of the registered product, and others. 

On 9 December 2022 the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published revised cosmetics control regulations, including new product categories and labelling requirements. The Control of Drugs and Cosmetic Regulations (CDCR) 1984 rules have outlined some standards that the companies who produce, market, sell, import, or keep the products are required to adhere to all those standards.

The following amendments are included in the update:    

• Three new cosmetics product categories have been added: hand sanitisers, sunscreen products, as well as essential oil for skin, hair, and nails.
• Before products may be marketed in Malaysia, they must be labelled in accordance with the regulations. Products in the vials or ampoules must be labelled "for external use only."
• A Halal logo may be used on a notified cosmetic product, but it must be approved by the Malaysia Department of Islamic Development (Jabatan Kemajuan Islam Malaysia, JAKIM), or any Islamic entity recognised by JAKIM.
• In addition, the list of approved components for UV filters, preservatives, and colouring agents has been eliminated.
• The guidelines for Good Manufacturing Practise (GMP) have also been amended. New regional producers and manufacturing lines will now be inspected by the NPRA before being notified under the CDCR.
• The production facility's layout must be established and constructed in accordance with GMP guidelines.
• Manufacturers from other countries will need documentation of GMP compliance from an authorised body.
• Requirements for claims, product recalls and complaints are now included in the updated guidelines.

The Secretariat of Health of Mexico through the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) indicated that regulations on cosmetics, perfumes and products for the personal and home care industry will be updated in the country. 

This entity highlighted that with the participation of industry and other actors involved in the sector, three regulatory norms are going to be modified: 

• The Official Mexican Standard 259 on good manufacturing practices. 

• The Official Mexican Standard 189 on the labeling and packaging of products for personal hygiene. 

• The Agreement on Substances used to regulate the manufacture of cosmetics and perfumes 

According to the Secretariat, these three regulatory norms are sensitive for the industry and must be improved to avoid raising transaction costs and discouraging investment. Thus, over-regulations that affect consumers will not be maintained. The objective of these proposed new regulations is to protect the population against health risks by facilitating entry into the market of quality and safety products. 

The Mexican Ministry of Health indicates that these measures will be an example for the Pacific Alliance, an international organization made up of Chile, Colombia, Mexico, and Peru. 

 In December 2022, a memorandum was signed between Saudi Arabia and Japan at the first ministerial meeting of the Saudi Japanese Ministerial Dialogue for Energy. . The memorandum was about cooperation in the energy sector, including carbon recycling technology and the use of hydrogen and ammonia as a clean fuel source, to achieve a carbon neutral society.

 According to the two memoranda of cooperation, the two nations will advance the use of hydrogen in transportation and encourage the study and advancement of fuel ammonia and hydrogen technologies as well as their application at the local, bilateral, regional, and global levels. The two nations will also look into the possibility of conducting a joint study or pilot project that quickens the adoption of low-carbon fuels like e-fuel, gaseous fuels, methane, fuels made from CO2, and methanol as well as technologies like direct air capture, carbon capture, utilisation, and storage (CCUS), or carbon recycling.

As Russia’s invasion of Ukraine has disrupted energy supplies around the world, the two ministers also reaffirmed the importance of securing stable provisions by advancing dialogue between oil producers and importers.

Japan’s Minister of Economy, Trade and Industry Nishimura visited Saudi Arabia and Oman for discussions on the supply and stabilization of oil and liquefied natural gas and seeking cooperation in such new areas of hydrogen and ammonia.

Singapore proposes to regulate 12 new chemicals and chemical groups under the Fire Safety (Petroleum & Flammable Materials) Regulations (FS (P&FM) Regs).

The Singapore Civil Defence Force (SCDF) has identified 12 chemicals and chemical groups as chemicals and precursors under the Chemical Weapons Convention (CWC), which are currently regulated by Singapore Customs through the Chemical Weapons (Prohibition) Act (CWPA) and the Chemical Weapons (Prohibition) Regulations. From July 2023, SCDF will also be regulating these 12 chemicals and chemical groups under the FS (P&FM) Regs, which will require companies to apply for a P&FM licence for the import, storage, transport or conveyance by pipeline of these chemicals. This will help minimize the domestic security and safety risks posed by these chemicals and serve the objective of safeguarding public health and safety.

Chemicals proposed: