GPC Newsletter Aug-2021



Regulatory News

Canada’s health and environment ministries have urged the conditions on the use of phosphonic acid, P,P′-(1-hydroxydodecylidene)bis-, allowing the limited amounts of the anti-adhesive to be used in certain cosmetic products. Since the substance is toxic or capable of becoming toxic under the section 64 criteria of the Canadian Environmental Protection Act (CEPA) 

The ministerial conditions permit the informing entity to only use the substance to manufacture the following cosmetics at a concentration of 0.4% by weight or less: 

  1. leave-on hair styling products; 
  2. leave-on makeup; and 
  3. rinse-off cosmetics. 

Importation is also allowed, if the substance is present in any of the three cosmetic product categories at a concentration of 0.4% by weight or less. 

The Canadian government has finalised regulations to limit formaldehyde emissions from composite wood products and apply the country’s that generally align with that of US. 

The regulation will concern the import, sale and offer for sale of the products for indoor use in Canada, with some exceptions. The government has set the following maximum formaldehyde emission levels: 

  • 0.05 parts per million (ppm) for hardwood plywood; 
  • 0.09ppm for particleboard; 
  • 0.11ppm for medium-density fibreboard; 
  • 0.13ppm for thin medium-density fibreboard; and 
  • 0.05ppm for laminated products. 

Under the authority of the Canadian Environmental Protection Act, 1999 (CEPA), the rules also set recordkeeping, labelling and reporting requirements for the industry. The government has also finalised a directive on the testing of formaldehyde emissions to ensure consistent levels.  

Formaldehyde can irritate the eyes, nose and throat and aggravate asthma symptoms, especially in children. At higher exposure levels, it has been associated with cancer of the nasal passageways as concluded by the Health Canada.  

Most products imported or sold in Canada will have to meet the new requirements by January 2023, 18 months after their official publication date. Laminated products, however, have five years – until July 2026 – to comply with the emission limits, testing, and certification requirements.

Canada’s environment and health ministries have suggested including solvent violet 13 to the Cosmetic Ingredient Hotlist, a move that would restrict the dye’s use in cosmetics placed in the country.  

The two government agencies nominated to add the dye to Schedule 1 of the Canadian Environmental Protection Act (CEPA), that is, the country’s toxic substances list. To manage exposure risks, the government has recommended imposing potential bans or restrictions on the substance’s use in certain cosmetics through its addition to Health Canada’s Hotlist.  

The government proposed this upon the findings of 2018 screening assessment which concluded that exposure to the substance can increase one’s risk of cancer and lead to toxic effects in the kidneys, liver, spleen or bones. The colourant was one of seven anthraquinone substances assessed.  

The government said solvent violet 13 are not only used in cosmetics but also in candles, pet shampoos, and food packaging. However, no other exposure routes were identified as sources of concern beyond cosmetics. 

Interested parties may submit comments on the proposed risk management action and any other related information until 15 September. 

The ministries said the other six substances do not meet the criteria set out in section 64 of CEPA to justify a toxic substance listing. As a result, the government proposed taking no further regulatory action on: 

  •  pigment blue 60; 
  •  solvent violet 59; 
  •  solvent blue 36; 
  •  disperse red 60; 
  •  acid blue 239; and 
  •  9,10-anthracenedione, 1,4-diamino-, N,N′-mixed 2-ethylhexyl and me and pentyl derivs. 

On the 22nd of July 2021, the US House of Representatives passed H.R. 2467, the PFAS Action Act of 2021. This is a comprehensive framework for regulating 9,252 per-and polyfluoroalkyl substances (PFAS). Unlike a similar bill (H.R. 535) which was never considered by the Republican-controlled Senate in the last Congress, this bill was passed by a vote of 241-183.

The bill sets requirements and incentives, in a bid to limit the use of PFAs in the environment. All PFAS are to be tested by EPA for toxicity to human health and the environment.

Furthermore, the bill provides the following:

  • Designation of PFOA and PFOS as hazardous substances under CERCLA. They are also designated as hazardous air pollutants under the Clean Air Act.
  • EPA must decide within five years if the other PFAS should be labelled hazardous substances.
  • Unsafe burning of PFAs wastes will be prohibited and incentives are to be provided for helping community water systems that are contaminated by PFAS.

REACH (EC 1907/2006) is a regulation aimed at improving the protection of human health and the environment through a better and earlier identification of the intrinsic properties of chemical substances. (Source: EC)

The EC clarification and amendment apply to Annexes VI to X of the REACH regulation. It helps clear the unclear and inconsistent words in these annexes. The draft amendment says:

  • Regulation (EC) No 1907/2006 lays down specific registration duties and obligations on manufacturers, importers, and downstream users to generate data on substances they manufacture, import, or use, assess the risks related to those substances, develop and recommend appropriate risk management measures.
  • Annex VI to Regulation (EC) No 1907/2006 sets out information requirements referred to in Article 10, point (a)(i) to (v) and (x) of that Regulation. Annexes VII to X of that Regulation set out standard information requirements for manufactured or imported substances in various tonnes.
  • In June 2019, EC and ECHA agreed that specific information requirements in the Annexes to Regulation (EC) No 1907/2006 should be amended to provide more clarity on the obligations of registrants regarding the submission of information.
  • The requirements laid down in Annex VI, sections 1 & 2 to Regulation (EC) No 1907/2006 will be amended. This is about the requirements for general registrant information and substance identification information.
  • The specific rules for adaptation from the standard information requirements set out in Annexes VII to X to Regulation (EC) No 1907/2006 will be amended.
  • Specific rules for adaptation from the standard information laid down in Annex VII to Regulation (EC) No 1907/2006 on mutagenicity and aquatic toxicity will be amended to ensure clarity and valuable information.
  • The information requirements in Annex VIII Regulation (EC) No 1907/2006 on testing for mutagenicity, reproductive toxicity, and ecotoxicological information will be amended to clarify the obligations of registrants.
  • Information requirements on testing for mutagenicity in Annex IX to Regulation (EC) No 1907/2006 should be amended.
  • Annex X to Regulation (EC) No 1907/2006 should be amended to clarify specific information requirements on mutagenicity, developmental and reproductive toxicity, and ecotoxicological information.

Click on this to get a copy of the complete draft regulation and amended annexes. These amendments imply that some registration dossiers will have to be updated; therefore, a specified time (to be decided later) to apply them might be deferred.

The feedback period for this draft regulation is opened until the 19th of July 2021 (Midnight, CET). For the feedback to be taken into account for finalising the draft act, it must adhere to feedback rules, and you can find them here.

Indian Government is proposing to bring out a ‘Reference Document for Carriage of Dangerous Goods by Road’. These Dangerous Goods (DG) refer to substances that pose risks to health, safety, property, and the environment when transported.  

The main factors contributing to this action include: 

- Misdeclarations

- Incorrect or inadequate packaging

- Incorrect stowage

- Misrepresentations

- Mishandling and negligence

This is aimed at helping the industry, transporters and other users proactively take measures for safe and efficient transportation of hazardous goods. 

In April 2021, the Ministry of Chemicals and Fertilizers, Department of Chemicals and Petrochemicals, India, published several orders regarding BIS certification of 13 chemicals (see Table below).

These chemicals are added to the BIS Mandatory Certification list, indicating that manufacturers or importers who place these chemicals in the Indian market would need to comply with BIS and receive a BIS registration certificate before the activity. This requirement applies to both Indian and foreign manufacturers. The order comes into force after 180 days of its publication in the Official Gazette. To take 100 percent Polyester Spun Grey and White Yarn (PSY) as an example, manufacturers or importers would need to comply with BIS after October 13, 2021 (including this date), if they intend to continue using PSY in India.

Chemical Name

Applicable BIS standard

Compliance Date starts

100 Percent. Polyester Spun Grey and White Yarn (PSY)

IS 17265:2019

Tuesday, October 13, 2021

Polyester Continuous Filament Fully Drawn Yarn (FDY)

IS 17261:2019

Tuesday, October 13, 2021

Polyester Industrial Yarn (IDY)

S 17264:2019

Tuesday, October 13, 2021

Polyester Partially Oriented Yarn (POY)

IS 17262:2019

Tuesday, October 13, 2021

Polyester Staple Fibres (PSF)

IS 17263:2019

Tuesday, October 13, 2021

Polyethylene Material for moulding and extrusion
i) Low Density Polyethylene (LDPE)
(ii) Linear Low-Density Polyethylene (LLDPE)
(iii) High Density Polyethylene (HDPE)

IS 7328:2020

Tuesday, October 13, 2021

Styrene-Butadiene Rubber Latex

IS 11356:2020

Tuesday, October 13, 2021

Synthetic Micro-Fibres for use in Cement Based Matrix

IS 16481:2016

Tuesday, October 13, 2021

Linear Alkyl Benzene

IS 12795:2020

Sunday, October 18, 2021

Ethylene Vinyl Acetate (EVA) Copolymers

IS 13601:1993

Tuesday, October 13, 2021

3(N, N-DiEthyl) Aminophenol

IS 7686:2020

Tuesday, November 24, 2021

Methylene Chloride (Dichloromethane)

IS 4566:2020

Tuesday, November 24, 2021

Red Phosphorus

IS 2012:2006

Tuesday, November 24, 2021

On the 7th of July, the Ministry of Environment and Ecology of China (MEE) published a notification of “Letter on Soliciting Opinions on the "14th Five-Year Plan" National Hazardous Waste Standardized Environmental Management Assessment Work Plan (Draft for Solicitation of Comments)”. This working plan was published to better enforce the law on the Prevention and Control of Environmental Pollution by Solid Wastes.

Under this working plan, the provincial environmental protection department will undertake the evaluation work, while MEE-SEE will stand by to randomly check the evaluations. There are two major changes in this draft. Firstly, regarding the standards for hazardous waste, the threshold for industrial hazardous waste has changed. In addition, the grading system has also changed. Now, the full score is 70, but companies may get bonus points or lose points based on their behavior.  

The consultation will be opened from the 7th of July until the 19th of July, 2021. For more inquiries, please contact compliance@gpcregulatory.com.  

The National Medical Products Administration of China (NMPA) announced their working plan for the second half of 2021 on 5th July 2021. This working plan is based on the haircare products and children’s cosmetics work done in the first half of 2021.

This announcement said that children’s cosmetics and haircare products will still be the focus of the second half of this year. In addition to these are children’s toothpaste, eye and skin care products, anti-wrinkle and whitening creams, anti-acne, and anti-itch products. 16 cosmetics are added into the inspection list. The inspection will be conducted from the perspectives of heavy cosmetics, hormones, antibiotics, micro-organisms and preservatives contained in the products.

The local authorities will take the investigation’s responsibilities and they must finish all the inspection by 10th of October, 2021.

For more inquiries, please contact compliance@gpcregulatory.com.

China implemented CSAR in January 2021, and this was after 30 years of waiting. China recently took another massive step by approving its first cosmetics ingredients under CSAR. As recently published in the International Nomenclature Cosmetic Ingredient, the names of the new ingredients are acetylneuraminic acid and lauroyl alanine, with their concentration levels restricted at 2% and 20%, respectively.

This means that ingredients not listed on the final revised version of the Inventory of Existing Cosmetic Ingredients in China (IECIC) cannot be marketed or sold. Companies are expected to file or register such ingredients with the NMPA. And registrations also depend on if the ingredient has a special use as a preservative, whitener, amongst others.

To read more about China’s cosmetics registration and filling, check here.

National Institute of Environmental Research (NIER) in South Korea updated the Toxic Chemical Substances List on June 22nd, 2021. 

After the hazard assessment under K-REACH, 13 substances were revised, and 19 substances were newly added to the list. 

The revised substances are as follows: No. 97-1-9, No. 97-1-134, No. 97-1-250, No. 97-1-281, No. 97-1-297, No. 97-1-299, No. 97-1-309, No. 97-1-416, No. 97-1-423, No. 97-1-457, No. 97-1-466, No. 2002-1-529, No. 2017-1-762. 

The newly added substances are: from No. 2021-1-1038 to No. 2021-1-1056. 

Manufacturers or importers of these toxic chemical substances must identify and label them by January 1st, 2022. 

The National Institute of Environmental Research (NIER) in South Korea updated the chemical substance classification and labelling list on July 12th, 2021. This list includes name of chemical substances, unique number, CAS number, hazard code, labelling code, M coefficient, and UN number. 

This update includes revising details of 38 toxic substances, 5 restricted substances and 5 accident preparedness substances and the addition of 19 toxic substances. 

The toxic substances revised are as follows: No. 97-1-9, No. 97-1-90, No. 97-1-11, No. 97-1-93, No. 97-1-111, No. 97-1-134, No. 97-1-139, No. 97-1-188, No. 97-1-208, No. 97-1-250, No. 97-1-281, No. 97-1-297, No. 97-1-299, No. 97-1-300, No. 97-1-309, No. 97-1-377, No. 97-1-416, No. 97-1-423, No. 97-1-457, No. 97-1-466, No. 2000-1-513, No. 2001-1-518, No. 2001-1-519, No. 2002-1-529, No. 2003-1-539, No. 2004-1-545 , No. 2009-1-595, No. 2010-1-613, No. 2011-1-617, No. 2013-1-667, No. 2014-1-687, No. 2014-1-696, No. 2014-1-697, No. 2014-1-698, No. 2017-1-762, No. 2017-1-795, No. 2019-1-912, No. 2020-1-982. 

The restricted substances revised are as follows: No. 06-5-4, No. 06-5-8, No. 06-5-9, No. 06-5-11, No. 06-5-12. 

The accident preparedness substances revised are: No. 9, No. 18, No. 39, No. 76, No. 83. 

The toxic substances newly added are as follows from No. 2021-1-1038 to No. 2021-1-1056. 

Classification and labelling of chemical substances are subject to this update which came into effect immediately. 

A Global NGO network, International Pollutants Elimination Network (IPEN), based on its research, has found levels of Persistent Organic Pollutants (POPs) in almost all the free-range chicken eggs it collected near plastic waste disposal sites in 14 developing countries.

Therefore, the network is calling on these countries’ governments to phase out the use of hazardous chemicals in plastics and also refuse permits for chemical recycling pyrolysis plants.

According to their research, the food chain in developing countries is at high risk of contamination, resulting from plastic waste exportation and disposal practices. IPEN also described free-range chicken eggs as active samplers often used for chemicals in soils due to the accumulation of POPs in them.

Their study collected eggs from 25 plastic waste disposal sites. These include e-waste dismantling operations, landfills and recycling plants in 14 countries in Africa, Asia, Eastern Europe and Latin America. The samples collected were discovered to contain levels of dioxin – a POP released when plastic is burned.

Other discovered contaminants include Polychlorinated Biphenyls (PCBs), Polybrominated Diphenyl Ethers (PBDEs) and Per- and Polyfluoroalkyl Substances (PFASs) such as Perfluorooctane Sulfonate (PFOS). Countries found to have the highest levels of PBDEs in egg samples per the research are Tanzania and Ghana, comparable with the most e-waste contaminated sites on record in China.

Some of the proffered recommendations by IPEN include:

  • Phasing out of the use of hazardous chemicals in plastic, including any new plastics treaty agreed by UN countries
  • Establishing a right to know regulation mandating companies to publicly disclose toxic additives in products
  • Banning the recycling of plastic materials containing POPs; and
  • Refusing permits for pyrolysis plants producing fuels and auditing existing chemical recycling plants claiming to produce outputs for plastic production.

IPEN also called on companies to halt the usage of toxic additives in plastics and invest more in plastic-free alternatives whenever possible.

Through the Ministry of Employment and Labour under the Occupational Health and Safety Act, 1993, on 29 March 2021, the government of South Africa finally published its regulations concerning Hazardous Chemical Agents. This is a supersession of the country’s 1995 law of the Hazardous Chemical Substances Regulations which was published through the Government Notice (GN) No. 1179 of August 25, 1995.  The changes to the regulation are to align with globally accepted practices, for instance, concerning the UN Globally Harmonized System (GHS). Under the regulation, manufacturers and importers of chemical agents are expected to classify and provide Safety Data Sheets (SDSs), labels, and packaging according to GHS. Some categories were excluded, they include:

  • Explosives - all categories
  • Acute toxicity (oral, dermal, inhalation) Category 5
  • Skin corrosion/irritation, Category 3
  • Serious eye irritation/damage, Category 2B
  • Hazardous to the aquatic environment short-term (acute), Categories 2 and 3
  • Hazardous to the aquatic environment short-term (chronic), Categories 3 and 4

Who does it apply to?

The regulation applies to employers and self-employed individuals, including manufacturers, importers, and suppliers exposed to these Hazardous Chemical Agents while on the job. The exemption to the regulation’s applicability is in cases where the lead regulations or asbestos abatement regulation apply. The regulation also expects the following from employers:

  • Providing employees with the necessary Personal Protective Equipment (PPE);
  • Conduct training with employees that may be exposed to hazardous chemicals during their, including on GHS labels, signage and SDSs;
  • Undertake routines such as air monitoring to measure exposure to substances at workplaces and to warrant that employees stay below the threshold as specified in the annexes.

The new regulation calls for new safety obligations, chemical prohibitions, classification and labelling requirements. Companies have, therefore, been granted an eighteen (18) month transition period after which the regulation will take effect from September 29, 2022.

The Gulf Standardization Organization (GSO), on the 7th of July 2021 issued an update to the draft Gulf Technical Regulation No. GSO 2528/2021 "Cosmetic products – Technical Regulation of cosmetic and personal care products claims". This was done through Technical Committee No. 12 and the draft was prepared by the Kingdom of Saudi Arabia.

This regulation focuses on the criteria of cosmetic product claims and the basic requirements of acceptable claims of cosmetic products. It further proposes that any claim or advertisement of cosmetic products must comply with certain criteria, as provided by this regulation.

The functions, intended use, and scope of application of cosmetic products are mentioned in GSO 1953 “Cosmetic Products- Cosmetic Products Safety Requirements”. According to this regulation, any product that contains unacceptable claims will fall out of the scope of cosmetic products.

For the draft document, click on the link below:
https://tsapps.nist.gov/notifyus/docs/wto_country/OMN/full_text/pdf/OMN441(arabic).pdf

The Philippines’ Food and Drug Administration (FDA) recently had a consultation to examine the draft of Circular to prohibit the use, manufacture, importation/exportation, distribution, sale, and storage of medical products that contain mercury. Such products include: clinical thermometers; dental amalgam and its capsules; and blood pressure measurement devices.

As the Philippines abides by Minamata Convention, which prohibits the use of new mercury mines and suggests the phase out of existing mercury mines and products with mercury, the Philippines has included mercury, mercury compounds, and products added mercury into the chemical control order since 1997 through DAO 1997-38. The updated version of this regulation (DAO 2019-20) outlines the schedule to phase out various mercury added products in 2022 and the various types of production using mercury and mercury compound during 2018-2025.

Once the draft is approved, thermometers and sphygmomanometers containing mercury will not be allowed to circulate in the market 30 days after the Circular has entered into force; while dental amalgam capsules have a longer grace period till June 6, 2023.

 

p.13-14 phased out items:

https://chemical.emb.gov.ph/wp-content/uploads/2019/11/DAO201920MERCURY.pdf

https://www.fda.gov.ph/draft-for-comments-of-banning-of-all-mercury-containing-thermometers-sphygmomanometers-dental-amalgam-capsules-and-liquid-mercury-for-use-in-dental-restorative-purposes/

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