GPC Newsletter May-2022

Canada has presented a long-awaited proposal to impose strict restrictions on a range of long-chain PFASs and flame retardants, as well as bans on dechloranplus (DP) and decabromodiphenyl ethane (DBDPE). According to a Canada Gazette notice, adopting the proposal – which the Canadian government floated in a 2018 consultation document – would position the country to ratify and implement amendments to the Stockholm Convention on persistent organic pollutants (POPs) and help it achieve other environmental goals. 

The 'Prohibition of Certain Toxic Compounds Restrictions, 2022' would repeal and replace existing regulations prohibiting certain long-chain per- and polyfluoroalkyl substances, as well as persistent flame retardants. Within three years, the amended restrictions are expected to make the manufacture, use, sale, and import of DP and DBDPE, as well as items containing them, illegal. They also want to go to the "next step" of risk management for the following chemicals by eliminating current exemptions:
 

• perfluorooctanoic acid (PFOA);
• perfluorocarboxylic acids (LC-PFCA); 
• hexabromocyclododecane (HBCD); 
• and polybrominated diphenyl ethers (PBDEs), including decaBDE.

However, there are certain exceptions due to sunset. They include manufactured items containing PFOA and LC-PFCAs, an exemption for PFOS in certain photolithography processes and photographic films, and several carve-outs that had allowed the continued sale of products containing the regulated substances manufactured before 2017. According to the Stockholm Convention, an exemption will be granted until the end of 2025 for the use of aqueous film-forming foam (AFFF) containing PFOA or LC-PFCAs in emergency situations, as well as for testing reasons, provided emissions are properly contained and disposed of.

If no viable alternative exists, companies can seek permission to continue using DP, DBDPE, or HBCD for up to three years. Interested parties have 75 days to submit comments and 60 days to submit a notice of complaint requesting the government to create a board of review.

US EPA on the 29^th of April 2022, submitted a notification to World Trade Organization, to amend the regulatory decision on Volatile Organic Compounds (VOCs).  According to US EPA, VOCs are compounds that have a high vapor pressure and low water solubility. Many VOCs are human-made chemicals that are used and produced in the manufacture of paints, pharmaceuticals, and refrigerants.

Under the Clean Air Act (CAA), the agency proposes to add (2E)-1,1,1,4,4,4hexafluorobut-2-ene (also known as trans-1,1,1,4,4,4-hexafluorobut-2-ene, and HFO1336mzz(E); CAS number 66711-86-2) to the list of compounds excluded from the regulatory definition. The reason is that this compound makes an insignificant contribution to tropospheric ozone (O3) formation, that is, the chemical reaction caused between oxides of nitrogen (NOx) and volatile organic compounds (VOC).

The main aim of this proposal is to protect both human health and the environment. The subjects concerned include industries manufacturing/using HFO-1336mzz(E) for use in foam blowing and refrigeration, industrial gas, semiconductor machinery, chemical products, vehicle parts, and building manufacturing among others.

Comments on this close on June 27, 2022. And the proposed date of adoption and entry into force is yet to be determined.

A leading European research institute, Oeko-Institut opened a consultation to exempt lead restriction under the EU RoHS Directive for medical devices’ production. The expectation is to develop lead-free alternatives, which have been delayed due to the COVID-19 pandemic.

Representing the European Commission, the institute is assessing the application for use of lead in polyvinyl chloride (PVC) as a thermal stabiliser. Also, it is a base material used in amperometric, potentiometric and conductometric electrochemical sensors, all present in medical devices.

Previously, the EU gave an exemption on the restriction of hazardous substances (RoHS) in electrical and electronic equipment. This exemption expired in March and this new exemption is expected to remain for two years.

This decision was made in consideration of the delay that hospitals experience in using medical devices for patients, mainly to analyse creatinine and blood urea nitrogen in whole blood.

To comment on this consultation, you have till May 19 after which a decision might be made. You can view the exemption request here.

On May 2, 2022, the European Union released a draft to amend Annex XVII to Regulation (EC) No 1907/2006. The new amendment mainly concerns articles in which production includes the use of formaldehyde or formaldehyde-releasing substances that releases the substance into indoor air in concentrations beyond the limit. It also refers to road vehicles that have formaldehyde or formaldehyde-releasing substances added in their productions in which concentration in the vehicles’ interiors is higher than the allowed limit.

The new amendment specifies the limit for wood-based articles and furniture at 0.062mg/m³ and other articles at 0.08mg/m^3. For road vehicles, the restriction is set at 0,062mg/m³. Therefore, concerned products beyond the stipulated concentration limit cannot be placed on the market.

The new restriction is expected to come into force 36 months after its entry (for concerned articles) and 48 months after entry into force for road vehicles.

According to the American Cancer Society, Formaldehyde is an organic compound, a colourless gas with a strong smell used in producing building materials, household products and vehicles. The common way to be exposed to the substance is through inhalation which studies have shown to cause cancer in humans. The main aim of the new restriction is to reduce exposure to formaldehyde and protect the general public from such exposure.

The proposed date of adoption is the last quarter of 2022 and the proposed date of entry into force will be 20 days from its publication in the EU official journal. All comments are expected 60 days (July 1, 2022) from its notification (May 2, 2022).

Exports and products involved with perfluorooctanoic acid (PFOA), its salt forms, and PFOA-related compounds are banned after the European Commission makes addition to Annex V of the Prior Informed Consent (PIC) Regulation. Echoing the Stockholm Convention on Persistent Organic Pollutants (POPs), the entry of the chemicals is monitored and this further urges parties concerned to prohibit exports that contain such substances.

In Annex I of the PIC Regulation, export notification requirements for 22 chemicals are at the same time addressed. The regulated range includes 15 pesticides, 7 industrial chemicals, and all substances that contain benzene as a constituent at concentrations above 0.1% weight by weight. Imports of restricted chemicals under the effect of the PIC Regulation were seen to have decreased by 20% over the same period, though the number of substances exported was reported higher than in the previous year according to the European Chemicals Agency (ECHA).

The PIC Regulation amendments were published on April 20, 2022, and will enter into force on July 1, 2022, after which the EU exporters will have to specify their intention of exporting the chemicals listed and receive explicit consent from the import destination before exports take place.

According to the EU Commission, the EU executive is sketching an alternative to add the endocrine-disrupting chemical Resorcinol to the REACH candidate list. It had been consensually approved earlier in February with industry and member states, subsiding the once disputed scientific evidence behind the intention.

After the Commission corrected the voting outcome finalized by the REACH Committee in January to "no opinion" based on legal advice, the EU Commission has been forced to make a U-turn for the controversy over the decision of identifying resorcinol as a Substance of Very High Concern (SVHC). The misinterpreted vote by EU member states had delivered a split verdict instead of an endorsement of the draft regulation as initially understood.

In line with the legislation on comitology rules, the executive will either amend the draft decision seeking a potential compromise and reach a positive opinion between member states, or present the original draft decision to the appeal committee, aiming at reaching a positive opinion at a politically higher level. Despite the controversy, it is nonetheless not planned to reverse the draft implementation Decision.

In its original plan, it is ideal for the Commission to defer the SVHC decision until the new criteria of endocrine disruptors are developed under the Classification, Labelling, and Packaging (CLP) Regulation in the pipeline. However, strong opposition was argued from the Rescorcinol Task Force (RTF), for the status quo appeared unclear for concerned individuals regarding if the two above mentioned options would be available in practice.

The European Chemicals Agency (ECHA), together with the Member States reviewed a group of 148 bisphenols, of which 38 bisphenols have potential reprotoxic or hormonal effects.

Bisphenols are commonly known as endocrine disrupters for human health and the environment. Endocrine disrupters are slow to break down in the environment and it causes adverse effects on human health. According to ECHA, bisphenols are mostly used in manufacturing polymers or polymer resins, thermal paper, adhesives, textiles, and paper.

Since bisphenols are widely used, the recommendation is to enact a group restriction as the best way to manage the risks posed by the 30 bisphenols. Before now, three bisphenols have been identified as Substances of Very High Concern (SVHC). These chemicals are bisphenol A, bisphenol B, and 2,2-bis(4'-hydroxyphenyl)-4-methylpentane. For other group members in bisphenol, there is a need to generate more data before confirming the endocrine-disrupting and reprotoxic properties.

The European Commission updates the glossary of ingredient names commonly used in cosmetics production. This was done to correct the names of ingredients that were written incorrectly while some were updated to comply with the recent changes made in the Personal Care Product Council’s (PCPC’s) International Nomenclature of Cosmetic Ingredients (Inci) list. 

To this effect, companies have to ensure that the chemicals listed on their cosmetic products’ labels comply with the new list. The deadline to do this is April 29, 2023. This is a part of the EU’s vision and strategy for sustainability, which has started by changing certain regulations like this.

 You can access the glossary of the common ingredients’ names here.

On May 3, 2022, the European Parliament voted on a European Commission proposal to tighten the limits for the presence of Persistent Organic Pollutants (POPs) in waste. The proposal was earlier adopted by the European Commission.

The presence of POPs in waste is a barrier to the development of a circular economy, one of the major objectives of the European Green Deal.

The Commission proposal was presented on 28 October 2021. It would amend Annexes IV and V to Regulation (EU) 2019/1021 on persistent organic pollutants, introducing limits for the presence of the following POPs in waste:

• perfluorooctanoic acid (PFOA) and its salts and related compounds – found in waterproof textiles and fire-fighting foams;
• dicofol – a pesticide, previously used in agriculture;
• pentachlorophenol, its salts, and esters – found in treated wood and textiles

Additionally, it would tighten maximum limits for some POPs already included in the Regulation.

While the Parliament agrees with the overall approach of the Commission’s proposal, it is suggesting more strict maximum limits in order to achieve the vision set out under the European Green Deal’s Zero Pollution Action Plan and Chemicals Strategy for Sustainability.  

Parliament is also proposing that the Commission assess whether it would be convenient to amend EU waste legislation to recognize that waste exceeding the thresholds of the POPs Regulation is hazardous waste.

Negotiations between Parliament and the Council of the EU, representing the Member States, will now begin. Both institutions must agree on a final text, which will then become law.

The European Chemicals Agency (ECHA) and the European Food and Safety Authority (EFSA) announced on May 10, 2022, that an ongoing assessment of the health and environmental risks of glyphosate will be delayed. Glyphosate-based herbicides are the most widely used weedkiller in agriculture.

Under EU Regulation 1107/2009, concerning the placing of plant protection products on the market, active substances must secure approval from the European institutions before they can be used in plant protection products. Said approval is limited in duration  to a maximum of 10 years, although it can be renewed if requested. Both the initial approval and subsequent renewals are decided upon after a process where the Member States and the European Food and Safety Authority review the existing evidence on the substance’s health and environmental impacts.

Currently, glyphosate is undergoing procedures for the renewal of its approval under the plant protection products regulation (for which EFSA is the relevant EU agency), and for its harmonized classification under Regulation 1272/2008, on classification, labelling and packaging of substances and mixtures (handled by ECHA). The current approval for glyphosate under the plant protection products regulation will expire on 15 December 2022. However, the public consultations run by both agencies have seen very high levels of participation which – together with additional information provided by the applicants for the renewal – have added a significant amount of information to the dossier. 

This additional information will be thoroughly considered by the Assessment Group on Glyphosate (AGG), composed of four EU Member States (France, Hungary, the Netherlands, and Sweden). Therefore, EFSA and ECHA are postponing their findings to have enough time to assess the contributions submitted. The revised timeline for the remaining steps in the re-evaluation process and publishing of the assessment is July 2023. 

In light of the above, it is expected that the European Commission will expand the current approval until a decision can be reached based on EFSA’s recommendations. 
 

On April 27, 2022, the Department of Chemicals and Petrochemicals of the Ministry of Chemicals and Fertilizers, India, published the Quality Control Orders (QCOs) in Gazette notifications for eight chemicals in order to make Bureau of Indian Standards (BIS) standard mandatory.

The orders come in order on the 181st day from this publication in the Official Gazette (October 24, 2022), and each order applies to goods or articles specified yet shall not apply to such meant for export. Penalty for contravention of the provisions of each order would be ruled under the provisions of the Bureau of Indian Standards Act, 2016 (11 of 2016).

The concerned substances are:

• 1,3 Phenylenediamine (Quality Control) Order, 2022

1,3 Phenylenediamine shall conform to the corresponding Indian Standard specified; namely, IS 17450:2020, with the compulsory use of Standard Mark under a license from the BIS according to Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018 and title 1,3 Phenylenediamine — Specification.  The BIS is to certify and enforce authority respecting substance 1,3 Phenylenediamine as specified.

• Lauric Acid (Quality Control) Order, 2022

Lauric Acid shall conform to the corresponding Indian Standard specified; namely, IS 10931:1984, with the compulsory use of Standard Mark under a license from the BIS according to Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018 and title Lauric Acid — Specification. The BIS is to certify and enforce authority respecting substance Lauric Acid as specified.

• Acid Oil (Quality Control) Order, 2022

Acid Oil shall conform to the corresponding Indian Standard specified; namely, IS 12029:1986, with the compulsory use of Standard Mark under a license from the BIS according to Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018 and title Acid Oil— Specification. The BIS is to certify and enforce authority respecting substance Acid Oil as specified.

• Palm fatty Acids (Quality Control) Order, 2022

Palm Fatty Acids shall conform to the corresponding Indian Standard specified; namely, IS 12067:1987, with the compulsory use of Standard Mark under a license from the BIS according to Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018 and title Palm Fatty Acids— Specification. The BIS is to certify and enforce authority respecting substance Palm Fatty Acids as specified.

• Rice Bran Fatty Acids (Quality Control) Order, 2022

Rice Bran Fatty Acids shall conform to the corresponding Indian Standard specified; namely, IS 12068:1987, with the compulsory use of Standard Mark under a license from the BIS according to Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018 and title Rice Bran Fatty Acids— Specification. The BIS is to certify and enforce authority respecting substance Rice Bran Fatty Acids as specified.

• Coconut Fatty Acids (Quality Control) Order, 2022

Coconut Fatty Acids shall conform to the corresponding Indian Standard specified; namely, IS 12069:1987, with the compulsory use of Standard Mark under a license from the BIS according to Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018 and title Coconut Fatty Acids— Specification. The BIS is to certify and enforce authority respecting substance Coconut Fatty Acids as specified.

• Rubberseed Fatty Acids (Quality Control) Order, 2022

Rubberseed Fatty Acids shall conform to the corresponding Indian Standard specified; namely, IS 12124:1987, with the compulsory use of Standard Mark under a license from the BIS according to Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018 and title Rubberseed Fatty Acids — Specification. The BIS is to certify and enforce authority respecting substance Rubberseed Fatty Acids as specified.

• Hydrogenated Rice Bran Fatty Acids (Quality Control) Order, 2022

Hydrogenated Rice Bran Fatty Acids shall conform to the corresponding Indian Standard specified; namely, IS 12361: 1988, with the compulsory use of Standard Mark under a license from the BIS according to Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018 and title Hydrogenated Rice Bran Fatty Acids— Specification. The BIS is to certify and enforce authority respecting substance Hydrogenated Rice Bran Fatty Acids as specified.

Contact GPC for BIS related compliance advice, compliance@gpcregulatory.com

On April 5, 2022, a Quality Control Order (QCO) for a national standard covering the intermediate trimethyl phosphite has been released in India. Published by the Bureau of Indian Standards (BIS), manufacturers and importers of the substance must guarantee that it meets the standards given in Indian Standard (IS) 17412:2020 as of 5th October 2022.

At industrial locations and in production, trimethyl phosphite is utilised in formulation or repackaging.IS 17412:2020 (technical grade trimethyl phosphite) specifies the rules for using the material in products and other technical specifications. Under the BIS (Compliance Assessment) Regulations, 2018, enterprises manufacturing or importing trimethyl phosphite will need BIS certification to verify conformity and must display the BIS logo on all packaging starting in October.

The BIS Act of 2016 will penalise anyone who violates the QCO's provisions. However, this does not apply to items meant for export.

This new QCO came after the American Chemistry Council (ACC) chastised the Indian government for developing "antiquated, specific to the Indian market, and not based on worldwide norms" chemicals standards.

Recently, the Bureau of Indian Standards (BIS) published several updates for BIS standards. The updates address the following:

1. Grant of All India First License for “Plastic-Acrylonitrile-Butadiene styrene (ABS) Moulding and Extrusion Materials Part 1 Designation System and Basis for Specifications” as per IS 17077 (Part 1):2019;
2. Grant of All India First License for “Linear Alkyl Benzene” as per IS 12795:2020;
3. Grant of All India First License for “White Cement Based Polymeric Putty” as per IS 17545:2021;
4. Calcined Alumina - Specification IS 17441 Part 1 Non-Metallurgical Grade, Indian standard is available for public comment now.

These grants, which are released by BIS when the first BIS registration certificate is released for any standard, indicate that there will be no extension for the implementation date against that standard. It does serve as a wake-up call to the industry to get their BIS registration certificate as soon as possible for compliance with the standards. As for International audits for the mandatory certificate products in similar lines,  there has been no official statement released by BIS up to date.

Penalties for cases where the products fail to be certified prior to the deadline under the mandatory scheme are not pre-defined. If any non-compliance act is found by BIS in their raids, the penalties charged from the culprit might likely serve as punishment, which is usually defined on the degree of non-compliance and the volume of products seized.

To date, a total of 39752 BIS registration certificates have been released to Indian manufacturers and for foreign manufacturers, 1018 BIS registration certificates have been released. Another Indian standard, Calcined Alumina - Specification IS 17441 Part 1 Non-Metallurgical Grade, is now available for public comment.

In total, 52 chemicals are currently under BIS mandatory certification scheme.

The Bureau of Indian Standards (BIS) is reinvestigating the use of eight chemical standards in plastics, resins, moulding, and extrusion materials.

The standards cover: 

The standards outline all the procedures, sampling methods, and tests that companies must employ while working with these compounds.

The BIS also proposed changing some of the requirements, sample techniques, and testing in the following standards:

• polycarbonate moulding and extrusion materials(comment deadline: 21 May)  
• the 2018 positive list of colourants in FCMs (comment deadline: 19 June) 
• polyalkylene terephthalate (PET and PBT), their copolymers and list of constituents in raw materials and end products in FCMs (comment deadline: 20 May); and 
• styrene (vinyl benzene) (comment deadline: 17 June). 

On the 13^th of May 2022, the Central Government of India extended the enforcement date for three substances under the Quality Control Order (QCO).

The Quality Control Order is the regulation that requires concerned substances/chemicals to carry the Bureau of Indian Standards (BIS) certification mark. This mark certifies the substance/product’s quality and safety to the end-users and environment.

For this new extension, the concerned chemicals and their new dates are Methylene Chloride (November 20, 2022), Ortho Phosphoric Acid (December 10, 2022) and Polyphosphoric Acid (December 22, 2022). The delays, according to the DCPC, are due to a backlog of outstanding QCOs caused by COVID-related staff shortages and travel limitations, which have resulted in delays in inspections, sampling, testing, and certification of substances and goods. 

There are about 52 chemicals in total, under the BIS mandatory certification scheme. 

India has launched a consultation to update standards for titanium (rutile grade) and barium sulphate pigments, both of which are used in paints and varnishes. The draft amended standards, which were published on April 27 by the Bureau of Indian Standards (BIS), establish comment dates of:

• Barium sulphate is due on June 30th, and
• Titanium (rutile grade) is due on July 5th.

Both chemicals should have no more than 90ppm lead or lead compounds, according to the draft. Also, separately or in combination, limiting the following substances in them to a maximum of 0.1 percent by weight:

• mercury,
• mercury compounds,
• cadmium,
• arsenic,
• chromium VI,
• antimony, and
• their oxides

For barytes (naturally occurring barium sulphate) and blanc fixe pigments, the draft offers requirements as well as sampling and testing techniques (the precipitated barium sulphate). The substance is designed to be used as a paint extender. The substance, according to the draft, is:

• Type 1 (naturally occurring) or
• Type 2 (precipitated form) classification; and
• Lead or lead compound content, which was determined using the relevant Indian standard.

The titanium dioxide (rutile grade) draft establishes sampling and testing standards for rutile titanium dioxide, which is used as a pigment in the paint industry. It also suggests that:

• graded content is categorised as R1, R2, or R3; and
• in the form of a powder

Both drafts recommend that packaging be marked or labelled with the following information:

• The substance's name, maker, and trademark, if applicable,
• The month and year of manufacture; the substance's net mass,
• The batch and lot number,
• The maximum lead content,
• The toxic heavy metals content, and
• Any cautionary notes.

If the draft is approved, BIS will certify products that meet their requirements and place a conformity mark on the packaging.

On the 27^th of April 2022, India published a Quality Control Order (QCO) for a national standard encompassing the intermediate 1, 3 phenylenediamine. Manufacturers and importers of the substance must guarantee that it meets the standards given in Indian Standard (IS) 17450:2020 as of October 25. The QCO was published in the country's Official Gazette by the Department of Chemicals and Petrochemicals (DCPC).

The compound is primarily employed as an intermediary in the production of dyes, notably permanent hair dyes, and as a polymer additive. Depending on the amount of exposure, it might induce skin sensitivities, disorientation, liver and kidney damage.

Manufacturers, traders, and importers will be required to comply with the standards set out in the applicable standard by the Bureau of Indian Standards (BIS).

This includes limiting the usage of certain 1, 3 phenylenediamine compounds, such as:

• Maximum use of arsenic is 2ppm, and
• Mercury is 1ppm.

The standard also limits the amount of mercury in 1, 3 phenylenediamine used in permanent black hair colours to no more than 4% by mass, and no more than 3% by mass in brown and other coloured hair dyes. The BIS Act of 2016 will penalise anyone who violate the QCO's provisions.

The Ministry of Environment, Forest and Climate Change (MoEFCC) and the Central Pollution Control Board (CPCB) have developed an integrated guidance framework for chemical safety in isolated storage and industries subject to the Manufacture, Storage, and Import of Hazardous Chemicals Rules, 1989 (MSIHC Rules).This is in accordance with the National Environmental Court Order dated June 11, 2021.

This framework covers chemical accident scenarios such as hazardous chemical spills/leaks, fires, explosions, or other accidents resulting from hazardous chemical handling, and it provides guidance to industrial units for conducting safety audits in accordance with the Indian Standard IS14489: 2018 Code of Practice on Occupational Safety and Health Audit.

Furthermore, in 1948, India enacted the Factories Act to ensure the occupational safety, health, and welfare of workers in factories registered under the Act. The Control of Industrial Major Accident Hazards (CIMAH) Rules, established under Section 41B of the Factories Act, prescribe "Safety Reports" and "Safety Audit Reports" for facilities where serious accidents are a possibility. The MSIHC and CIMAH rules are enforced by the government of each state or union territory's Chief Inspector of Factories (CIF) or Directorate of Industrial Safety and Health (DISH). The government of the state or union territory has control over the details of companies that fail safety audits and the actions taken against such companies.

On April 22, 2022, China National Center for Food Safety Risk Assessment (CFSA) announced a consultation notice on approving two new resins used in food contact materials and an expanded use of one food contact material additive.

The concerned substances in this notification are:

• Addition of two new resins
  • hexane, 1, 6-diisocyanato-, polymer with poly (oxy-1,2-ethanediyl), α-methyl-ω-hydroxy- – for use in adhesives with indirect contact with food in moderation according to production needs; and
  • 1,4-benzenedicarboxylic acid, polymer with 1,3-benzenedicarboxylic acid, 2,2,4,4-tetramethyl-1,3-cyclobutanediol, 1,4-cyclohexanedimethanol, 1,3-propanediol,2-methyl, and adipic acid – for use in paints and coatings at a maximum level of 80% (based on dry weight)
• Expansion of the use of one additive
  • 2-(5-chloro-2H-benzotriazol-2-yl)-6-(1,1-dimethylethyl)-4-methylphenol (CAS 3896-11-5) as a food contact additive for use in polystyrene (PS) – This is in addition to its current approved use in polyethylene (PE) and polypropylene (PP) plastics. 

If the above proposal is approved, the substances will be included in the national standard of GB 9685-2016 and adhere to the requirements in GB 4806.1. before they can be used in food contact materials.

The deadline for consultation is 20^th May 2022. 

If you have any opinion or inquiry relating to China regulations, please contact GPC at compliance@gpcregulatory.cn or zhengming@cn.gpcregulation.com for help.

Follow us on our WeChat official account: 全球产品合规GPC

Or

add our WeChat account: 46 0708381983 (GPC China)

On April 27, 2022, the General Department of the National Medical Products Administration (NMPA) extends the deadline for submitting certain data under the cosmetic regulation from May 1 until December 31. This decision was made due to the rising cases of COVID-19, lock-downs and restrictions in main cities like Shanghai.

This update outlines the new date for cosmetics registrants or filers to supply certain data under the country’s overarching cosmetic regulation – the Cosmetics Supervision and Administration Regulation (CSAR).

This includes: 

• product classification codes for cosmetics that have been approved before May 1, 2021; and 
• product efficacy summaries for cosmetics approved between May 1 and December 31, 2021. 

Since January 1, businesses have been required to substantiate statements made on labels regarding a product's functioning, such as whitening. This is needed when submitting registrations or filings for new products under the CSAR. They also have to submit to the NMPA website, a summary of data in support of all the claims on the labels or marketing materials of finished cosmetic products.  

According to the April 27 notice, companies can submit electronic documents without company stamps and supply stamped documents once COVID-19 is under control. 

On the 28^th of April 2022, the Ministry of Environment, South Korea submits a draft on the labelling and advertising of chemical products.

With comments expected to close 40 days from notification, the proposal will be adopted after June 2022 and come into force in August 2023. The notification recommends tighter regulations on the labelling and advertising of chemical products by restricting the use of certain phrases. The phrases include phrases that can be misunderstood as non-toxic, as having no negative impact on the environment/nature, and as having no negative effects on humans/animals. It also restricts phrases that may mislead consumers to think there is no harm which can then lead to excessive use or incorrect use of the product.

The Ministry of Food and Drug Safety (MFDS) in South Korea updated the regulation on precautions when using cosmetics and labeling of allergens under Cosmetic Act on April 27^th, 2022. This is due to the update of the enforcement rule of the Cosmetic Act.

The main updates are as follows:

1. Updates on classification of cosmetic types and precautions for using cosmetics (Annex 1)

• Classifying cosmetic types and removing some cosmetic types
• Integrating precautions by cosmetic type and precautions by ingredient

2. Addition on precautions for each cosmetic type (Annex 1)

• Adding precautions on the cosmetic type ‘Vulvar Cleanser’

Annex 1.2.1.6 (precautions on vulvar cleanser products) and Annex 1.2.1.9 (precautions on aerosol products with high-pressured gas) will come into effect from Dec 19^th, 2022.

All other amendment will come into effect from June 19^th, 2022.

The Ministry of Food and Drug Safety (MFDS) in South Korea updated the regulation on cosmetic safety standards on April 1^st, 2022. This is to strengthen the safety management of cosmetics and protect public health, as well as strengthening the competitiveness of the cosmetics industry.

The main updates are as follows:

1. Addition of prohibited raw materials for cosmetics and reinforcement in usage restriction standards (Annex 1 & 2)

• Adding some components of persistent pollutants and perfluorinated compounds to raw materials that cannot be used
• Prohibiting benzalkonium chloride (BKC) for spray products

2. Establishment of exceptions for raw materials that cannot be used in cosmetics (Annex 1)

• Establishing management standards for cannabis that can be unintentionally included from certain parts of cannabis (Tetrahydrocannabinol and Cannabidiol from hemp seed oil and hemp seed extract)
• Setting a permissible limit for radioactive materials that may exist in nature
• Setting a permissible standard of Fluorescent Brightener 367, which are raw materials prohibited for use in cosmetics, based on the risk assessment result

3. Addition of raw materials that can be used as hair dyes and setting an upper concentration limit (Annex 2)

• Adding 10 ingredients that can be used for hair dye and setting the upper concentration limit for using it based on functional cosmetics examination cases

4. Modification of terminology according to clarification of raw material names and revision of upper laws and regulations (Annex 2 & 3)

• Modifying phrases related to the upper concentration limit when using ‘p-methylaminophenol’
• Revising “cosmetics manufacturer and distributor” to “responsible cosmetic distributor” reflecting the amendments of the Cosmetics Act

Part of Annex 2, updates on Benzalkonium Chloride and Indigofera Leaf Powder, will come into effect from October 1^st, 2022.

All other amendment came into effect immediately.

Two amendments were announced to mandate inspection requirements for commodities subject to Restriction of Hazardous Substances (RoHS) regulation in Taiwan on February 24 and March 15, 2022. They were announced by the Bureau of Standards, Metrology and Inspection (BSMI), Ministry of Economic Affairs (MOEA) of Taiwan. The effective date of these revised inspection standards is February 22, 2022, whereas the old standards are invalid starting from January 1, 2024.

A total of 53 commodities are subject to RoHS regulation, and Section 5 “Marking of Presence” of CNS 15663 (2013) is included in all these inspection standards. The two new amendments cover the requirements for commodities like printers, storage devices (i.e. hard disk drives, HDD), monitors, etc., as shown in the table below.

For a commodity subject to a declaration of conformity, the declaration of conformity will be invalid from January 1, 2025, according to the explanations of these notices. It is therefore recommended for manufacturers or importers concerned to update the declaration of conformity accordingly before December 31, 2024.

To further explain the application scope for all the products, an explanation of exemption conditions is made, “Products belonging to medical devices or telecommunications terminal devices are excluded”. For some products with expanded application scope, for instance, “machines for receiving, converting, transmitting, or reproducing sound, images, or other data”, a gateway is added to the application scope of inspection standards; a rechargeable electric pencil sharpener is as well added to the application scope of the inspection standard of pencil sharpener, which will be subject to products imported or manufactured in Taiwan after January 1, 2024.

CNS 15598-1 (revised in 2020) limits requirements for mercury content in cold cathode fluorescent lamps and induction lamps (<500 mm: 3.5 mg or less, 500 mm ~ 1500 mm: 5 mg or less, > 1500 mm: 13 mg or less).

* CNS 15663: Guidance to Reduction of the Restricted Chemical Substances in Electrical and Electronic Equipment (Taiwan national standard related to RoHS).

The amendments to the “List of Ingredients Prohibited from Using in the Cosmetic Products” were made on April 27, 2022, by the Ministry of Health and Welfare of Taiwan. The statement stipulates that cosmetics should not contain mercury, lead, or other ingredients banned for use by the central competent authority, formulated from the upper-level law of the List, Article 6, Paragraph 1 of the Cosmetic Hygiene and Safety Act.

Conclusively, the manufacture, importation, sale, supply, or display (for the purpose of sale or supply) of cosmetics that contain the ingredients listed in the statement is prohibited. This revision mainly focused on 4 ingredients - Alanroot oil (Inula helenium L.), Rauwolfia serpentina L., alkaloids and their salts, Yohimbine and its salts, and Tripterygium wilfordii Hook.f., which together with the newly-revised list will come into effect from July 1, 2022.

To prevent and handle the environmental and health concerns arising from the use of the substance; polyvinyl chloride (PVC) in Food Contact Materials (FCMs), Taiwanese authority is making efforts to ban the production, import, and sale of FCMs that contain PVC, currently scheduled from July 1, 2023.

The ban applies to both food/plate packaging materials as well as designated recyclable or disposable tableware containers produced with PVC. The categories of products affected include those intended for animal food, dairy products, drinks, and seasonings.

Plate packaging materials are defined as the plastic lining, blister and plate containers, which must be recycled in accordance with Taiwan’s Waste Disposal Act. Plasticisers like phthalates are added to make PVC flexible. The potential migration of plasticisers into foods or drinks brought about by the use of PVC dwells in FCMs containing PVC, which can moreover release toxicants such as dioxins and heavy metals into the environment as the items are burnt in disposal management, according to an Environmental Protection Agency (EPA) announcement.

Under Taiwanese food packaging standards, some other types of phthalates, i.e. DEHP, DBP, BBP, DNOP, DIDP, DINP, DMP and DEP, have either been banned or restricted previously by the EPA. The recycling fees for PVC packaging are also gradually raised so as to steer the industries to safer chemical usage alternatives.

The Occupational Safety and Health Administration, Ministry of Labor of Taiwan released a question-and-answer format of the SDS checklist on April 21, 2022. This is to encourage the downstream users and companies of chemicals to verify the contents of SDS provided by the upstream manufacturers. Further, it will make upstream manufacturers verify their own Safety Data Sheet (SDS) more carefully.

Verification of items categorized under the following 5 groups is required:

1. Conformity of contents to be listed in accordance with related laws and regulations
2. Whether the information on hazardous ingredients is appropriate or not
3. Consistency with GHS classification
4. Whether the SDS test data is appropriate or not
5. Consistency of content description in SDS.

For example, a clearer indication of category 2 “If the information on hazardous ingredients is appropriate or not” of the checklist is listed in the following table with the options of Yes/No/Unconfirmed to be chosen from:

On March 25, 2022, a regulation mandating toys to conform with the Thai industrial standard for toys, TIS 685 Part 1-2562 (2019) Toys: Safety requirements Part 1 – Requirements, was published in the Royal Gazette of Thailand by the Ministry of Industry. This published regulation, “Ministerial Regulation regarding designation of Toys as industrial products which shall conform to the industrial standard” is effective from September 22, 2022.

The standard restricts the migration of chemicals in TIS 685 Part 1-2562 (2019) for toy products. A stricter threshold was found for finger paint except for Barium, in contrast to “TIS 685 Part 1-2540 (1997) Toys Part 1 General requirements”. The specific requirements stated in the regulation are as follows:

The standard also introduced new requirements on phthalates in plastic, rubber, and coating.

The Thailand Department of Industrial works and Ministry of Industry Recently published a notification, in the Royal Gazette on 11 April 2022.  This notification is referred to as “Notification of Department of Industrial works regarding criteria and Method for Registration and Notification of Specialized Person Responsible for Safety Storage of Hazardous Substance under Authorization Of Department of Industrial Works and Reporting of Safety Storage of Hazardous Substance B.E 2565 (2022)”. It prescribes responsibilities of the hazardous substance storage facility and the qualified licensed person responsible for safety. This notification shall enter into force on 1 May 2022.

The new set of appendices consist of the following;

A report of hazardous chemicals’ safe storage is to be submitted by the Hazardous Substance entrepreneurs using the BorChor.6 form annually for the period of a calendar year. The submission is expected by 31 March next year via an online system of the Department of Industrial Works. However, in 2022, entrepreneurs are allowed to submit the annual report by 31 August 2022 as part of the transition measures.

A new version of the Japanese online tool, Globally Harmonized System (GHS) Mixture Classification and Labelling Creation System (Nite-Gmiccs) from the National Institute of Technology and Evaluation (NITE) has been released.

The latest version comes with upgraded functions, such as assisting users to create safety data sheets (SDSs). The fixed bugs include issues relevant to systematic layout, SDS labels, Acute Toxicity Estimates (ATE) for mixtures and individual ingredients, and duplications of mixture identities when importing mixture composition information, etc. It is available as a free version via the NITE’s website. Information like the composition of chemical mixtures or the GHS classification of pure chemical substances is recommended for making relevant classification’ labels.

The new function for SDSs also allows users to directly transpose results from GHS classification as well as to classify mixtures and ingredients to SDSs into the required format. This new feature in the system eases previously existing administrative burdens substantially for either authorizing authorities or the SDSs creators.

Advantages of this function also include easier access for users’ reference to the applicable Nite Chemical Risk Information Platform (Chrip) law and regulation information from the Cas registry number of the composition component of the products. This can also at the same time be exported to the SDS formats. Timely updates on related regulatory changes and other news information regarding existing substances listed under the Ministry of Health, Labour and Welfare (MHLW)’s Industrial Safety and Health Act (ISHA) and the Ministry of Industry, Trade and Economy (Meti)'s Chemical Substances Control Law (CSCL) are also provided in version 2.0.2.

Other detailed upgrades include:

• To display "Non-medicinal Deleterious Substances" and "Non-medicinal Non-toxic Substances" required for labels under the Poisonous and Deleterious Substances Control Law, and
• To calculate the ATE even in cases where all the composition components of the mixture or product are shown as "Not applicable to the category".

The Australian authority on the 13^th of May 2022 announced the addition of six chemicals to the Australia Inventory of Industrial Chemicals (AIIC). The assessment certificates of these chemicals have been issued according to Section 82 of the Industrial Chemical Act 2019.

Any registered introducer; namely, importers or manufacturers of chemicals, are entitled to introduce the chemical substances listed in the AIIC. According to the regulating Act 2019, the introducers are required to register industrial chemicals before introducing them to Australia, during the registration year from September 1 to August 31. However, those listed in AIIC need an assessment certificate from the Executive Director to introduce such industrial chemicals

The table below provides detailed information about the newly added chemicals.

The Australian Government published a variation of specific information requirements regarding 1H-1,4,7-triazonine, octahydro-1,4,7-trimethyl- (CAS No. 96556-05-7) on May 4, 2022. The modification and publication are done in accordance with Section 93 of the Industrial Chemicals Act 2019.

This chemical has been assessed under the Industrial Chemicals (Notification and Assessment) Act 1989, and any registered introducer (that is, manufacturers and importers) can introduce this to Australia based on the Australia Inventory of Industrial Chemicals (AIIC) list.

The published notice states that for 1H-1,4,7-triazonine, octahydro-1,4,7-trimethyl- (CAS No. 96556-05-7), the introducers (importers and manufacturers) of this chemical shall notify the Executive Director in writing in 28 days when either of the following situations is met (excerpted from Variation of Specific Information Requirements).

• The importation volume of the chemical ≥ 10 t/y; or
• The concentration of the chemical in paints or coatings ≥ 3%.

The Brazilian Health Regulatory Agency notifies World Trade Organization (WTO) of several resolutions for cosmetics and personal hygiene products which are proposed to enter into force with the earliest start being on May 2, 2022. Earlier in March 2022, Brazilian Health Regulatory Agency (ANVISA) announced a few regulations regarding technical requirements and defined criteria for either labelling or composition of applicable products.

For product manufacture, the conditions for chemical use of lead acetate, formaldehyde, paraformaldehyde and pyrogallol are stated, which also internalizes another resolution from the national legal system MERCOSUR (GMC MERCOSUR Resolution number 48/2010).

Extra attention has been put on personal hygiene products (PHPs) as much as on cosmetics, especially on detailed information displayed such as labelling of composition, warnings, and technical definitions like the inclusion of substance concentration, etc. General rules for exporting Brazilian-made products and temporary regulations applicable with regard to the emergency international public health state under SARS-CoV-2 are also proposed; for instance, on the manufacture and marketing of antiseptic preparations or sanitizers.

Resolutions aforementioned are mostly expected to start from May 2, 2022, with no applicable final date for comments; whereas resolution for the obligation to label product composition in Portuguese (i.e. Resolution - RDC number 646)’s entry date is scheduled for November 1, 2023.

According to notifications from World Trade Organization (WTO), several resolutions for medical devices are proposed to enter into force with the earliest start being on May 2, 2022, by the Brazilian Health Regulatory Agency. Earlier in March 2022, Brazilian Health Regulatory Agency (ANVISA) announced a few regulations regarding technical requirements and defined criteria for medical devices.

In alignment with International Medical Device Regulators Forum (IMDRF) and its issued document IMDRF/RPS WG/N9 (Edition 3), ANVISA has also provided resolutions focusing on regularizing the software-form of medical devices (Software as a Medical Device - SaMD). Another resolution is issued on hardware medical devices including in vitro diagnostic products and the Good Manufacturing Practices (GMPs) required are issued and further incorporated into the MERCOSUR system.

Resolutions aforementioned are mostly expected to start from May 2, 2022, with no applicable final date for comments; whereas resolution for SaMD (i.e. Resolution - RDC number 657) is scheduled to be adopted from July 1, 2022.

The Brazilian Health Regulatory Agency (ANVISA) is responsible for regulating and approving guidelines and use of pharmaceutical drugs, sanitary standards, and regulation of the food industry. In the last month, ANVISA has proposed modifications to active ingredients employed in agrochemicals and revised provisions for personal hygiene products.

Through Normative Instructions (IN), ANVISA proposes to include the following active ingredients in the ingredient list used in Agrochemicals, Sanitizing Disinfectants and Wood Condoms, which is regulated by IN 103/2021:

In addition, proposal 1085 aims to modify substances present in IN 103/2021 annexes, i.e., the frequent need for toxicological assessment or reassessment of referred active ingredients. Proposal 1089 also intends to revise further 15 active ingredients with a public consultation open until June 5, 2022.

In a resolution published in May 2022, ANVISA also targeted disposable personal hygiene products. Among the list, brushes and sticks for oral hygiene, dental floss and tape, disposable sanitary pads, menstrual cups and swabs went under new regularization rules. RDC 640/2022 also defines the classification, technical requirements, and labeling instructions for such products to be marketable in Brazil.

Among the directives, ANVISA requires that product owners submit a notification via the online portal containing product technical information. Product owners can look up which detailed data is mandatory in RDC 640/2022 Annex I, to know to which extent they should be present.

Furthermore, ingredients that may migrate to the skin and/or mucous membranes must comply with the requirements set out in the respective lists of substances for personal care products, cosmetics and perfumes, according to their classification.

Latin American countries have been constantly improving their chemical management instruments in the last few years. Among several meetings and discussions, countries are motivated to pursue the implementation of their national chemical policy.

The Latin American Regulatory Cooperation Forum (LARCF) has been front running with events and cooperation partnerships in the region, bringing together more than 100 regional industry members. The most recent meeting (April 2022) once again shed light on the risk approach to chemical management, highlighting the importance of national chemical inventories.

In the published document, Risk Approach in the Management of Industrial Chemical Substances and Products – Inventories, the Forum explains the importance of chemical inventories in driving chemical policies forward. However, it recognizes that inventories need to be accompanied by mechanisms to identify substances and mixtures offering unreasonable risks to health and the environment, i.e., substance prioritization, risk assessment, and measures for risk management.

The report also insists that governments develop inventories open to data exchange as individual and isolated inventories often bring duplication of data, delay trades, and increased expenses. The OECD Mutual Acceptance of Data (MAD) is pointed out as a solution in this case.

LARCF has already published a Roadmap for Sound Management of Industrial Chemicals in September 2020 and seeks future publications and guidelines related to substance prioritization, risk assessment, and risk management.

From a regional perspective, only Chile and Colombia have implemented their national chemical inventories. In contrast, other countries still have to figure out their implementing regulations and/or ways to drive the process forward in the political scenario.

The Chilean Ministry of Environment published on May 10, 2022, Resolution 240/2022 to better identify products that fall under packing materials and further indicate the corresponding categories. The provision is aligned with the Decree 12/2020 that entered into force in 2021.

In turn, Decree 12/2020 introduced recycling, recollection, and other obligations to manufacturers of containers and packing materials. Decree 12/2020 defines containers and packing as those materials used to contain, protect, handle, facilitate consumption, store, preserve, transport, or improve the product presentation. In case an article comes integrated or attached to the product, it is also considered a packing element. The same applies to goods aimed at informing consumers.

Resolution 240/2022 brings an extensive list identifying those products treated as packing materials and hence subject to goals imposed by the regulations. The list divides the packing material according to their use categories, i.e., food, cleaning products, personal care products, health, horticulture, tools, clothes and shoes, and home, among others, and contains more than 145 examples. Furthermore, the regulation also brings criteria to further classify the materials into residential and non-residential.

As Chile publishes regulations to implement extended producer responsibility, businesses must be attentive to changes and new obligations to come.

Chemical policies are rapidly developing in Latin America. National Chemical Regulations are the main focus of regional cooperations as well as projects initiated by international organizations. A number of countries have been drafting chemical management frameworks. Countries like Brazil, Chile and Colombia are taking a step further to put these regulations in place. Here is the summary of what you should expect for compliance requirements in Latin America in 2022:

• Argentina is expected to publish a more comprehensive and revised draft regulation since the last draft version dates from September 2019.
• Brazil progressed with its chemical regulatory law in December 2021 when the Deputies’ House Environmental Commission approved the bill. The draft still must be approved by another three in-house commissions after formal sanction.
• Colombia is the most recent country to enact its chemical management in November 2021. Colombia will likely announce its National Inventory in May/June 2022.
• Costa Rica has been involved in several meetings for technical and operational discussions involving chemical administration. Costa Rica is focusing on first implementing the Registry of Releases and Transfers of Pollutants (RETC in Spanish).
• Chile, the first country in Latin America to adopt a solid framework for chemicals, is waiting to publish the risk assessment criteria and guidelines to drive chemicals prioritization. The National Inventory only comes in 2025.
• Peru's single regulatory draft bill was submitted for public comments in September 2020, which is still under process. However, the country has been moving closer to OECD membership, signaling a resumption of activities.

The 2022 World Circular Economy Forum (WCEF) will hold in October, in Kigali, Rwanda. This will be hosted by the Republic of Rwanda, the African Circular Economy Alliance (ACEA) and The Finnish Innovation Fund Sitra.

Africa is gradually moving towards developing its chemical sector and one of such moves is aimed at enhancing a circular economy. Through WCEF2022, Rwanda aims to showcase Africa’s interest in developing the region for a circular economy. This was affirmed by the Minister of Environment in Rwanda, Jeanne d’Arc Mujawamariya.  Finland agrees with this new development, confirming Africa as a vast continent that plays a significant role in having a global circular economy. Therefore, hosting the event in Africa is a good step for the global world.

Rwanda is a landlocked country in Central Africa where there is the convergence of the African Great Lakes region and Southeast Africa. Rwanda is a founding member and Co-chair of the African Circular Economy Alliance. It has also been at the forefront of the transition process to a Circular Economy in Africa and the world at large. Moreover, the country recently developed its first Circular Economy Action Plan.

South Africa opened a consultation until April 29, 2022, to consult on the migration limits for 19 substances used in toy production. This new draft standard is aimed at upgrading South Africa’s toy regulations to sync with the EU’s latest regulatory updates for toys. This draft, SANS 50071-3 Ed 2 will fit with EN 71-3:2019 standard in the EU and will address the requirements and test methods for the migration of the concerned 19 substances. In the draft, toys are categorised into three with specific migration limits, all based on the possibility of substance intake. The three categories include:

Category I: Dry, brittle, powder like or pliable materials

Category II: Liquid or sticky materials

Category III: Scraped-off materials

Liquid toys can be easily ingested, therefore, this category has the weightiest limits while the ingestion rate for plastics is lower, thereby classifying them in the category with the least weighty limits. The concerned 19 substances are aluminium, antimony, arsenic, barium, boron, cadmium, chromium (III), chromium (VI), cobalt, copper, lead, manganese, mercury, nickel, organic tin, selenium, strontium, tin, and zinc. It is important to note that this standard does not apply to toys that have no hazard from sucking, licking, swallowing or long period of skin contact with them. South Africa has also opened consultations for some standards which include mechanical and physical properties test requirements and methods, prohibited flammable materials in toys and requirements for flammability of toys, requirements and test methods for substances and materials used in toys, requirements and test methods for trampolines (used domestically), and their access devices and enclosures (used both outdoor and/or indoor).

The opened consultation (now closed) of this draft standard significantly indicates the upcoming changes to expect in South Africa. The full draft can be viewed here.