GPC Newsletter Mar-2023

ECHA, the European Chemicals Agency, has updated its guidance for importers and manufacturers of polymers and monomers to comply with minimum requirements for REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) regulations. The changes include updated registration obligations for importers and manufacturers. The updated guidance includes changes to the monomer registration requirements, the calculation of registration tonnages, and the information required in chemical safety reports. ECHA is urging all relevant parties to review their REACH registrations to ensure compliance with the updated guidance.

To access ECHA polymer and monomer guide click here: https://echa.europa.eu/-/guidance-for-monomers-and-polymers

The revision of the FCM Regulation has been long-awaited, with the Regulation not having been reviewed since its entry into force in 2004. In May 2020, the Commission announced that it would adopt a proposal for the revision in the fourth quarter of 2022. However, due to the Regulation being “complex” the revision was postponed to 2023.

Recently the Commission's Department on Health & Food Safety (DG Sante) revealed that work on the revision would not begin until 2025. The Commission's numerous proposals announced under the REACH and CLP revisions have added to the challenges, with questions arising over the extent to which these policy options, including essential use criteria, should be factored into the work on updating the FCM Regulation.

Despite the delay in legislative work, DG Sante has outlined plans for 2023 to refine solutions and define more detailed policy options for the revision of the FCM Regulation. The focus will be on policy pillar A: 'shifting the focus onto the final material' and pillar B: 'prioritisation of substances'. Together, these pillars will form the core of the future risk management approach, with new material categories being applied.

The goals for pillar A are for producers of final FCMs to have full knowledge of 'migratables' and to become solely accountable for their release above the permitted safe levels. DG Sante's objective is also for all migratables to be risk assessed by national authorities or potentially businesses, as outlined in pillar B.

Under pillar B, the directorate will also create three tiers. The first is generic rules that will apply to the use of the most hazardous substances. Tier two will see public authorities conducting risk assessments, while the final tier envisages business operators assessing "more benign" chemicals.

In addition to these pillars, DG Sante plans to work on a study to assess the impact and options of pillar C – 'supporting safer and more sustainable alternatives'. The study is expected to be submitted to the Commission's regulatory scrutiny board by Q1 2024.

It has furthermore been pointed out that the drafting of the proposal is likely to clash with the European elections in May 2024 and the appointment of a new college of commissioners six months later. This could further delay the proposal, depending on other priorities such as dealing with the cost-of-living crisis and energy security.

If the proposal comes out in 2025, a revised regulation might not come into place until 2026 or 2027.

The Waste Framework Directive's database (WFD) for information on substances of concern in articles as such or in complex objects (products) is known as Substances of Concern In Products (SCIP). As of January 5, 2021, businesses who provide goods with Substances of Very High Concern (SVHCs) on the Candidate List in a concentration greater than 0.1% weight by weight (w/w) to the EU market must provide the European Chemicals Agency (ECHA) with information on those products. Over a product's entire lifespan, even when it is in the disposal stage, the SCIP database makes sure that information on items containing chemicals on the Candidate List is accessible. The database's data is subsequently made available to waste management professionals and end users. 

 The German Environment Agency and 20 additional partners from 13 EU member states launched the AskREACH project in 2017. Its objective was to improve supplier and customer understanding of and communication regarding SVHCs. The EU amended the WFD a year later and opted to launch the SCIP database. As it was being developed, ECHA and AskREACH frequently discussed a potential alignment or shared entry format for the two systems. These programs aimed to broaden the dissemination of information regarding SVHCs to garbage operators, consumers, and other supply chain users. n. Since, for instance, SCIP utilises different identities [for chemicals and articles], the alignment of SCIP and the AskREACH consumer app was discovered to be impractical. 

On January 25, 2023, the AskREACH final conference was held in Brussels. High-level speakers  brought up the necessity for Art. 33's implementation and the requirement that products made and sold in Europe be safe for both the environment and consumers. 

The conference also heard repeated requests from NGOs and authorities for the Commission to shorten the period of time that businesses have to respond to requests for information on SVHCs in articles, as required by REACH Article 33. This mandates that anybody selling items that contain more than 0.1% of an SVHC by weight must warn their clients and offer usage tips within 45 days of doing so. 

The obligations and goals of the Article 33. are not being met, according to representatives from business and NGOs. Participants at the conference attributed this to a lack of knowledge about customers' rights and duties among consumers, retailers, and suppliers, as well as consumer challenges with requests and suppliers' poor, incorrect, or non-responsive responses. The AskREACH project has proposed several measures to the Commission to strengthen Article 33, including: requiring businesses to respond to consumer inquiries even when the article contains no SVHCs > 0.1%, or an obligation to always inform consumers; defining who is responsible for providing SVHC information in cases of online trade, for example, by amending REACH's definition of "supplier;" 

Nevertheless, members of the AskREACH initiative reminded the conference that in order for suppliers to properly respond to customers, they must have a working supply chain communication system in accordance with Article 33(1) and be ready for the requests. 

On 6th March 2023, the Ministry of Environment, Urbanization, and Climate Change of Turkey announced that the data sharing guide within the scope of the Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals (KKDIK) has been updated. Regarding the sharing of data and costs required between multiple registrants of the same substance for KKDIK are the parts that have been changed with the updated guide. This data-sharing guide contains practical advice to help companies fulfill their data-sharing obligations and detailed explanations about other situations where data sharing is recommended and other processes.

In the updated guideline, the basic principles and rules regarding data and cost-sharing are explained. It is recommended by the Ministry that companies should comply with the KKDIK Regulation and data sharing guide for data and cost-sharing. If there is any conflict for data sharing with the scope of KKDIK, the Ministry will take into consideration whether each party complies with the obligations set forth in the guide. 

With KKDIK deadline, December 2023 is approaching, we recommend industry representatives to complete the registration process under KKDIK and make use of any available guide or documents provided by the Ministry. If you like to learn more about available guides or registration process for KKDIK, you could contact GPC.

On March 14, 2023, the Indian Chemical Council called for a stakeholder meeting concerning making BIS Standards mandatory for 76 chemicals. These chemicals are listed under international conventions to which India is a signatory or as Hazardous Chemicals notified by Ministry of Environment, Forest and Climate Change (MoEF&CC) under the Manufacture, Storage, and Import of Hazardous Chemicals (MSIHC) Rules, 1989.

Since 2018, 63 chemicals have been added to the BIS compulsory list (Scheme I) with individual timelines for implementation. Out of these substances, 25 have been implemented, another 38 chemicals are due to be added during 2023 according to the published Quality Control Orders (QCO).

Industry stakeholders are encouraged to submit their comments even after the meeting. Share your comments directly to the BIS (here) or send them to our BIS team at compliance@gpcregulatory.com

On February 2nd the department of agriculture and farmers welfare of India published a new guideline and regulation on insecticides. This regulation with code name S.O.701(E) is intended to prohibit and limit the use of certain insecticides. This regulation has been in debate for the past 7 years and will come into force after it is published in the official Gazette.  

Based on this regulation the following changes would come into force regarding the use of insecticides: 

1. Certain insecticides will be prohibited (table 1). 

2. Based on this regulation no individual or company is allowed to import, manufacturer, sell, and distribute the mentioned insecticides 

3. All certifications which are issued for the registration of the mentioned insecticides will be called back by the registration committee.  

4. For those individuals whose registration is void and have not complied to the act, action will be taken after 3 months. 

Table 1. The List of prohibited Insecticides are listed below: 

Furthermore, the department of agriculture and farmers welfare of India has also published a list (table 2) of crops which would be omitted from approved usage of insecticide’s label claim. Base on this law those registrants which have granted a certificate, shall submit their certified along with label and leaflet, in order to delete their label claims.  This information should be submitted to the Secretary, Central Insecticides Board and registration Committee, NH-IV, Faridabad, within six months from date of publication of this Order. 

Table 2 

On 30 January 2023 the Ministry of India notified a new amendment regarding the exemptions for solar panels and medical devices. 

The notification stated that companies producing solar panels and medical devices are exempted from the requirements of the E-waste (management) Amendment Rules 2023 which is to come into force on 1 April 2023.  The E-waste (management) Amendment Rules 2023 mean that the manufacturers, sellers or importers of solar panels and related equipment and medical devices will no longer be required to provide information about the amount of restricted hazardous substance in their products for the user documents. They will however be required to perform conformity assessments, retain that information and submit it to India’s Central Pollution Control Board upon request.   

Furthermore, the following substances will still be allowed for use:  

• Cadmium and lead in solar panels/cells, photovoltaic panels/cells/modules 

• Lead in medical devices (except for implanted and infected products) 

On 23 March 2023, the State Administration for Market Regulation of China (SAMR) announced the “Toothpaste Supervision Management Measures” will be enforced from 1 Dec. 2023. According to the regulation, toothpaste is defined as “a paste-like product that is applied to the surface of human teeth in a frictional manner for the main purpose of cleaning”. 

Within “Cosmetic Supervision and Administration Rules” (CSAR), toothpaste was required to be complied according to normal cosmetic products. To enforce this article, Toothpaste regulation was published. It specified the requirements and procedures for toothpaste registration. After the enforcement of this regulation, toothpaste registration should be carried according to it and not the CSAR regulation. 

There were in total 25 articles which regulate the following aspects: 

• General rules which are about definition, classification, and supervision bodies. 

• Labelling and efficacy claim requirements.

• Registration requirements and procedures, relevant technical standards. 

Manufacturing and importing are not allowed until a certificate is granted. For more information regarding toothpaste regulation, please contact GPC via compliance@gpcregulatory.cn.

The National Health Commission of China is consulting on proposed modification to the country’s main standard regulating food contact materials (FCMs), GB 9685-2016. GB 9685-2016, Standard for the Use of Additives in Food Contact Materials, contains a positive list of additives that is allowed to be used in FCMs and articles conditionally or unconditionally as prescribed in the standard. 

The new modifications lower the migration levels for following substances:

• 4,4'-methylenedianiline – to be amended to 0.002mg/kg. 

• 2-ethylhexanol – to be amended to 30mg/kg. 

• 1,2,4-benzenetricarboxylic acid – to be amended to 5mg/kg.

• eugenol to be introduced as not detected. 

• a polysiloxane with Cas number 156065-00-8 to be introduced as not detected; and 

• m-xylylenediamineto to be introduced at 0.05mg/kg. 

Additionally, companies are still allowed to use the additives currently permitted for use in food. The consultation is open until 20 March. If you would like to know more information about China regulatory requirements, please contact compliance@gpcregulatory.cn, 

National Istitutes for Food and Drug Conrol of China (NIFDC) published notification calling for suggestions on “Cosmetic Safety and Technical Guidelines”. “Cosmetic Safety and Technical Guidelines” is the main cosmetic safety standard under the “Cosmetic Supervision and Administration Regulation” (CSAR). It was published first in 2015 and modified in 2021. It gives information about the requirements and proceudres for cosmetic ingredient and final product test, risk assessment and toxicology test requirements. 

Currently, the modifications made in last year’s draft has been approved. The main changes in last year’s draft were: 

• Amending the list of ingredients approved and banned for use;
• Introdcuing more test methods for physical and chemcial inspection, , toxicological test methods and human efficacy test methods; and  
• Including new requriments for safety assessment report to keep in line with CSAR. 

All stakeholders can submit suggestion before 17 March. If you want to know more information about China cosmetic and chemical compliance, please contact compliance@gpcregulatory.cn for help. 

The National Institute of Environmental Research (NIER) in South Korea notifies new approval application submission deadline for daily use consumer chemical product subject to safety verification and approval under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR) on March 16^th, 2023.

This is for the companies manufacture or import biocidal products subject to 2024 approval deferment among daily use consumer chemical product subject to safety verification. New approval application submission deadline for daily use consumer chemical product subject to safety verification and approval is June 30th, 2023, and companies should submit via Chemical product management system (chemp.me.go.kr). Please note that the system would be closed for the new approval application submission after the deadline.

If you have any questions regarding this notification, you can contact NIER (1800-1253).

The Ministry of Environment (MoE) in South Korea consults on a draft amendment of ‘the Designation of Consumer Chemical Products and Standards for Labelling and Safety’ on February 27^th, 2023. There has been a request from the industry, and this is to allow some substances as a preservation material in spray types of products that has been confirmed as safe to use through risk assessment. 70 substances have been allowed to be used as a preservation material in products.

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

The deadline for this consultation is March 20^th, 2023.

On February 16, 2023, the Environmental Protection Administration Executive Yuan of Taiwan announced the notice “Regulated businesses and requirements for restrictions on packaging used in internet shopping”, which will come into effect on July 1, 2023.

The regulation applies to internet retailers but individual retailers on e-commerce platform are exempted.  The restrictions include:

• Packaging materials cannot contain polyvinyl chloride (PVC)

• Paper packaging boxes and bags and cardboard products should use the material of the original colour and the mixed rate of recycled paper should be more than 90%.

• The blending ratio of recycled materials should be 25% or more for plastic packaging boxes/bags and cushioning materials.

To reduce the use of plastics, the authority also requires companies with capital above 50 million NTD to work on:

• For goods with weight between 250 gram and 1 kilogram, the weight ratios between packaging and total weight should be less than 40 %.  

•  For goods with weight between 1 kilogram and less than 3 kilograms, the weight ratios between packaging and total weight should be less than 30 %. 

• For goods with weight above 3 kilograms, the weight ratios between packaging and total weight should be less than 15 %. 

To encourage the reduction of plastic packaging, the authority also sets goals for companies with capital above 150 million to reduce to 25 % by 2024, 30% by 2025 and 35 % by 2030. 

On 12 January 2023, Taiwan’s EPA announced the amendment of the notice “List of chemicals of concern subject to control and management requirements for handling them”, adding 15 concerned chemical substances to the list. Out of the 15 newly added substances, it includes 5 chemical substances with food safety risks and concern, 8 explosive precursor chemicals, and 2 new psychoactive substances.

After the announcement, the 15 substances have been immediately prohibited from being traded online or on other platforms that cannot identify the trading parties. Existing handlers shall obtain approval documents and meet labelling requirements before 1 February 2024. Existing handlers should also submit monthly declaration. For new handlers, however, there is no grace period of such.

Appendix one – chemicals that concerns people livelihood 

English Name

CAS No.

Announced Date

Nitrous Oxide

1002 4- 97-2

2023-01-12 (updated)

Hydrogen Fluoride

7664 -39- 3

2023-01-12 (updated)

1,4- Butanediol

110- 63-4

2023-01-12

(S)- 5,6,6a,7- tetrahydro1,2,9,10- tetramethoxy-6- methyl-4H-dibenzo[de,g]quino line

475- 81-0

2023-01-12

Appendix two – chemicals that has food safety concern 

English Name

CAS No.

Announced Date

Lead monoxide

1317- 36-8

2023-01-12

Lead tetroxide

1314- 41-6

2023-01-12

Sodium sulfide

1313- 82-2

2023-01-12

Sodium thiocyana te

540-72- 7

2023-01-12

Β-Naphthol

135-19- 3

2023-01-12

Appendix two – explosive chemicals 

English Name

CAS No.

Announced Date

Ammonium nitrate

6484 - 52 - 2

2023-01-12 (updated)

Calcium nitrate

10124 - 37 - 5

2023-01-12

Sodium nitrate

7631 - 99 - 4

2023-01-12

Calcium ammonium nitrate

15245 - 12 - 2

2023-01-12

Nitromethane

75 -52 - 5

2023-01-12

Sodium azide

26628 - 22 - 8

2023-01-12

Ammonium perchlorate

7790- 98-9

2023-01-12

Sodium perchlorate

7601- 89-0

2023-01-12

Aluminium phosphide

20859- 73-8

2023-01-12

The Japanese Ministry of Health, Labour, and Welfare (MHLW), Ministry of Economy, Trade, and Industry (METI), and Ministry of the Environment (MoE) held consultations on 18 February 2023, regarding a ban on the production and import of PFHxS and its salts, as well as the import of some product types containing them, through a partial revision to the Chemical Substance Control Law's (CSCL) Enforcement Ordinance. The action aims to bring the nation into compliance with a global PFHxS ban adopted by the Stockholm Convention on POPs last year.

According to the announcement, comments were given a deadline of 19 March 2023.

The three ministries designated the substance as a Class I specified chemical. According to the CSCL, Class I specified chemicals are those that Japan has determined to be persistent, extremely bioaccumulative, or which have a risk of long-term toxicity to humans.

In Japan, the Poisonous and Deleterious Substances Control Law (PDSCL) designates poisonous and deleterious substances according to their acute toxicity level. On 26 January 2023, the Ministry of Health, Labour and Welfare (MHLW) issued a proposal to designate 3-Aminopropan-1-ol and its mixtures with a concentration of 1% or more as a Deleterious Substance.

The MHLW has categorized 3-Aminopropan-1-ol as Category 1 Skin corrosion/irritation as well as serious eye damage/eye irritation in line with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) standards established by Japan. The selection of Deleterious Substances is mostly based on these risk groups.

Manufacturers, importers, and distributors of this substance have the obligation to register this substance with the MHLW and are subject to Safety Data Sheet and labelling requirements under the PDSCL.

The MHWL took public opinions on the proposal until 24 February 2023. The changes are anticipated to be completed on 25 May 2023, and go into force on 1 June 2023.

The Ministry also plans to remove Diantimony tetraoxide from the list of Deleterious Substances and change the concentration cut-off for 2-Isobutoxyethanol from 10% to 15%.

Hair dyes and "quasi-drugs" are governed under the Pharmaceutical and Medical Devices Act in Japan. Before producing or promoting their products, businesses must first meet registration requirements and receive approval from the Ministry of Health, Labour and Welfare (MHLW).

 The MHLW announced in two separate notifications on 23 December 2022, that it will remove two additives from its list of additives for quasi-drugs products and one from its positive list for hair dyes. They become operative on 1 January 2023.

Methylrosaniline chloride and Stearyl dimethyl amine are removed from the approved list for quasi-drugs. The updated list consists of total 2746 additives. Two additives i.e. Hydrogenated Lanolin and Methoxyethylene Maleicanhydride Copolymer, are also renamed to "Lanolin, Hydrogenated" and "Methoxyethylene Maleic Anhydride Copolymer" respectively. The names of further six additives such as N-Acetyl-L-Cysteine, Ethanolamine, Synthetic Zeolite, etc. are also revised.

The positive list for hair dyes was also updated to eliminate methylrosaniline chloride and also renamed the additive "3-Propanol (Reagent)" as "2-Propanol (Reagent)". There are a total of 1848 additives in the most recently updated list.

The additives are used in pharmaceuticals and health products as well as some cosmetic products like skin whiteners, deodorants, hair coloring dyes, etc.

On 26 December 2022, the Ministry of Health, Labour and Welfare (MHLW) of Japan released a notice containing new requirements for several substances to its food contact materials (FCMs) positive list for polymers.

On April 2020, the ministry published its first draft positive list of substances under the amended Food Sanitation Act of Article 18(3), which became effective on 1 June 2020. Companies were granted a five-year transition period until 31 May 2025, during which they may comply with the regulation. Enforcement is set to begin on 1 June 2025.

Substances on the positive list are currently divided into two tables:

The revision of table 1 for polymers is based on industry comments on the April 2022 proposed draft tables. A revised draft of table 2 for additives is anticipated to be released in early 2023.

The ministry has revised numerous existing compounds, such as ester of methacrylic acid with ethylene glycol, aromatic hydrocarbon and ethylene glycol or oxirane with new standards, limits, and conditions for use. For several compounds like 1, 4-butanediamine, butyl acrylate, methyl methacrylate, etc. the ministry eliminated the pre-existing standards.

The MHLW has also updated the names of compounds in English and Japanese as well as the CAS and code numbers in the notice.

On 11 January 2023, the Chilian environmental authority approved Resolution 15 which aims to control the import of hazardous substances to the country and authorizes the GHS-based “List of Classification of Substances”. Additionally, Resolution 15 includes a list of substances and mixtures that are classified as dangerous.  

Hazardous chemicals listed in Table 1 of Article 5 of the Resolution require importers to obtain a Customs Destination Certificate and an Authorization of Import, Use and Disposition. The Regional Secretariats of Environment are responsible for the authoring of these documents. 

The list of substances is, nevertheless, not exhaustive, and therefore, some hazardous chemicals are subject to additional specific regulations that are not covered by Resolution 15. These are among others: hazardous chemicals that are considered weapons; liquids and gases of general use; ozone layer-depleting substances; radioactive substances; equipment that generates ionizing radiation; formulations of pesticides for exclusive agricultural use; and chemical weapons. Importers of these chemicals must comply with the specific regulations that apply to them. 

According to Colombia’s Resolution 0773/2021, chemical manufacturers exporting to Colombia need to be aware that the transition period for implementing GHS in the workplace finishes on 7 April 2023 for pure chemical substances and 7 April 2024 for mixtures. After the deadline, companies must start using the sixth revised edition of GHS for labelling and classification.  

With Decree 1496/2018, Colombia implemented the 6th revised edition of GHS for activities related to the extraction, production, importation, storage, transportation, distribution, trade and any other use of hazardous chemical products.  

Resolution 0773/2021 applies to public and private employers, dependent and independent workers, contractors, apprentices, trainees, and cooperative workers who handle chemical products at work, whether pure chemicals, diluted solutions, or mixtures of these. Chemical products should be classified according to the sixth edition of the Globally Harmonic System of Classifying and Labelling Chemicals (GHS6), as well as the use and management of labels and Safety Data Sheets (SDS).  

Labelling must be in Spanish and conform to the requirements listed in GHS6. Information on prevention, response, storage, and disposal should be included, unless they are already listed elsewhere. The labels may include the nominal quantity and lot number of the chemical in the container.  

The size of the label should be proportional to the container’s size and shape. Product names and hazard pictograms must not be displayed on containers smaller than 30 millilitres. 

The SDS must include occupational exposure limits determined by the American Conference of Governmental Industrial Hygienists (ACGIH) at the time of its preparation or updating. In this same section, the type of recommended personal protection elements should be specified, specifying characteristics such as glove material and type of filter, among other specifications. 

A draft Regulation governing the creation, marketing, and import of cosmetic items has been published by Israel's Ministry of Health. Israel sent the draft to the WTO on January 24.  Comments are accepted until 25 March and the draft does not indicate a timeline for implementation.

There are annexes with a list of 329 banned ingredients and 1,683 chemicals that cannot be used in cosmetic products; it also contains affirmative lists of UV filters, preservatives, and color additives that are allowed.  With a few minor exceptions, these are virtually identical to those in the annexes to the EU cosmetic products Regulation.

The Israeli list is stricter than the EU one as some chemicals on Israel's list of prohibited substances are not listed on the EU equivalent list. These include; troxerutin, SD alcohol 40, and desmedipham.

The nation's proposal also complies with EU regulations on testing procedures and guidelines for designating a responsible individual for each cosmetic item.

Singapore has recently updated its standards for chemical classifications, labelling, and safety data sheets (SDSs) to conform to the seventh version of the UN's Globally Harmonized System (GHS) of chemical classification and labelling. These updates, which took effect on February 6th, are mandatory for companies involved in the manufacture, import, supply, use, or handling of hazardous substances in Singapore.

They are outlined in Singapore Standard (SS) 586 and changes include:

-  increased labelling and training requirements,

-  the addition of a new appendix with guidance on labelling for small containers,

- alignment with GHS requirements for toxicity values,

- revised SDS requirements,

- the addition of a new appendix providing guidance on describing and determining the empirical data of a substance or mixture,

- an updated annex that permits the use of generic and masking names to safeguard confidential business information (CBI).

To read more about Singapore chemical regulation and news related to it, click here: https://www.gpcgateway.com/common/regulation/NDQ-/U2luZ2Fwb3Jl