GPC Newsletter Oct-2021

Dear sir and madam,

 

The biggest holiday in India is here!

Diwali is a huge celebration in India, which we recognize at GPC. This is a festival of lights celebrated to mark the beginning of a new year.

GPC wishes you and your family a very Happy Diwali and Prosperous New Year! May we all grow together and touch new heights of success this coming year!

 

Shisher Kumra,

Executive Director, GPC



Regulatory News

To get ahead of problems that can impact those who make and use PFAs, the US EPA has issued a 26-pages roadmap to set an approach for research, restricting, and remediating these chemicals.

According to the EPA Administrator, Michael Regan, "This comprehensive, national PFAS strategy will deliver protections to people who are hurting, by advancing bold and concrete actions that address the full lifecycle of these chemicals." 

This new roadmap includes the following:

  • Imposes new testing and reporting requirements, strengthening the TSCA review of new PFAs

  • Tightens restrictions on existing ones.

  • Adopts an enforceable drinking water limit for perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS)

  • Applies hazardous substance designations for certain substances.

  • For substances not yet on the market, EPA will apply a rigorous premanufacture notice review process for new PFAS to ensure these substances are safe before they enter the market.

All these changes are in addition to the earlier revised assumptions about proper usage of personal protective equipment (PPE) and the lack of approval for PFASs submitted through a low volume exemption (LVE). 

Furthermore, to review and tighten restrictions on existing PFAs, EPA plans to issue TSCA section 5(e) orders and impose rigorous safety requirements as a condition of allowing the use of PFAs. You can download a copy of the roadmap here.

Last Update: 2021-10-21

In October 2021, US EPA removed the confidentiality status for 377 substances, making their chemical status available to the public. According to the TSCA inventory, these chemicals make up about 8,000 of the 42,000 chemicals listed there.

In April, EPA listed 390 substances that will be moved to the public section of the inventory. Industries were given a period to raise concerns about the declassification of these chemicals. Of the 390 substances, 13 were found on the public inventory, and some were reported for having invalid accession numbers. This warranted a few changes before US EPA published the 377 substances to lose confidentiality status.

This list includes substances reported by companies as non-confidential in a CDR submission and those flagged during the inventory reset proceed from 2017 to 2018. As released by EPA, it will also be included in the next TSCA inventory update this year.

 

Last Update: 2021-10-26

On the 28th of October 2021, the European Commission adopted the proposal on protecting human health and the environment by tightening the limits for POPs. Persistent Organic Pollutants (POPs) are the most harmful chemicals in waste, and the proposal is targeted at preventing these chemicals from entering the economy.

The European Commissioner for the Environment, Oceans, and Fisheries, Virginijus Sinkevičius, acknowledges that this is one more step to fulfill their promise to remove the most harmful pollutants from our daily lives.

POPs are no longer used in new products. However, they are still found in the waste from consumer products like waterproof textiles, plastics, electronic equipment, and furniture.

The Commission then proposes strict limits for the following POPs:

  • 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.

Furthermore, the Commission wants to tighten the maximum limits in waste for another five substances.

This is a vital step towards achieving a more circular economy, contributing to the European Green Deal's Zero Pollution Action Plan and the Chemicals Strategy for Sustainability.

Latest Update: 2021-11-02

The European Chemical Agency (ECHA) announced the SCIP Database in September 2021; this is a public database for Substances of Very High Concern (SVHC) in EU products. SCIP database is aimed at helping consumers make informed purchasing choices and waste operators develop procedures for reuse and recycling of articles and materials respectively. 

About 6,000 companies in the EU have notified ECHA about their products that have SVHCs, therefore, the SCIP database has more than four million article notifications which can now be accessed by the public. 

According to ECHA, the most notified product categories in the database are: 

  • machinery and their parts 

  • measuring instruments and their parts 

  • electronic equipment and their parts 

  • vehicles and their parts 

  • articles made of rubber; and 

  • furniture. 

And the most common SVHCs in these notifications are: 

  • lead (e.g. in ball bearings, batteries); 

  • lead monoxide (e.g. in lamps, vehicle parts); 

  • lead titanium trioxide (e.g. in electric cookers); 

  • silicid acid, lead salt (e.g. in lead crystalware, vehicle coatings); and 

  • 1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15- diene, more commonly referred to as “Dechlorane PlusTM” (e.g. in paints, glues) 

In the database, you can easily search for data either by the name or brand of the article, type of material, product category, or by the chemical name. Through the database, you can get accurate information on products; if they are hazardous and their safe use instructions. 

Do you place articles that contain SVHCs in the EU market? If yes, have you notified these substances to the database? If no, you must do the notifications. Check ECHA for guidance documents and tools for this process. 

As it started on January 5, 2021, notifying ECHA applies to companies that supply articles containing substances of very high concern (SVHCs) on the REACH candidate list. This obligation concerns articles in the EU market that contains more than 0.1% weight by weight of SVHCs.  

Last Update: 2021-10-20

As published on the website of the official gazette, the Turkey cosmetic regulations’ annexes were amended in September. The parts that were amended include:

  • Annex 2 (List of forbidden substances)Annex 3 (List of substances that cosmetic products shouldn't contain above determined amount)
  • Annex 4 (List of colorants allowed in cosmetic products)
  • Annex 5 (List of allowed preservatives in cosmetic products
  • Annex 6 (List of UV filters allowed in cosmetic products)

The amendments state that:

  1. Hair and eyelash dye products that contain Benzene-1,2,4-triol, 6-amino-m-cresol, and 2-((4-amino-2-nitrophenyl)amino)benzoic acid can’t be put into the market anymore (applicable from 3rd of September 2021). According to hazard classification and labeling of ECHA, those substances cause serious eye damage, skin irritation and may cause respiratory irritation. Additionally, products with these substances can stay in the market until the 3rd of June, 2022. 
  2.  Products that contain 2-hydroxyethyl methacrylate which causes serious eye damage, and 7,7,9-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate which is harmful to aquatic life can’t be sold in the market anymore (applied from 3rd of September 2021). These substances are mainly used in nail products. 

 To find out more about Turkey cosmetic regulations and for other related inquiries, contact compliance@gpcregulatory.com

Latest update: 2021-10-20

On the 27th of September 2021, the new Turkish Food Codex Maximum of Pesticides Residual Limits Regulation was published on the official gazette, after a public consultation on the draft in 2020. 

Like the Turkish Food Codex Maximum of Pesticides Residual Limits Regulation 2016, this regulation aims to protect consumers by regulating maximum pesticides residues in plants and animal source foods. 

In summary of the regulation for imported goods, firstly, product code can be found in Annex 1. By using that product code, MRL (Maximum Residue Level) or LOD(Limit of Determination) should be found in Annex 3 for specific pesticides and you should comply with those. If pesticides can’t be found in Annex 3 then 0,01* mg/kg calculation applies. 

Forbidden pesticides are listed in Annex 4. If pesticides listed in Annex 5 are found in imported products, then no MRL is required.  

That regulation entered into force on the publication date, 27th of September, 2021, and the previous regulation is revoked by the new one. The provisions of this regulation are executed by the Minister of Agriculture and Forestry. 

 

Latest Update: 2021-10-20

 

On the 17th of September 2021, India overturned its ban of recycled plastic in 2018, now allowing the use of recycled plastic in Food Contact Materials (FCMs). The exception to the new rule is that it doesn’t include chemical migration limits, that is, manufacturers can also recycle plastics containing harmful substances and use them for food packages.

The amendment, which came into effect six days after, states that recycled plastics may be used for storing, dispensing, and packaging ready-to-eat foods and drinks if it meets FSSAI appropriate standards and regulations.

The document by FDA makes it clear that it is a current thinking on the topic and so, should not be legally enforced but viewed as recommendations. It also states that recyclers of plastics intended for food packaging should submit process information to the FDA for evaluation and comment, though not legally binding.

A draft notice has also been published by FSSAI to set specific migration limits for the use of three substances in all FCMs. This is inclusive of plastics used for drinking water packages. The substances and migration limits include:

  • antimony – 0.04 milligrams per kilogram (mg/kg);
  • phthalic acid – 1.5mg/kg; and
  • bis(2-ethylhexyl) phthalate – 1.5mg/kg.

For this period, objections, suggestions, and feedback can be submitted. The authority declared it will consider the proposed amendment to be effective 60 days from its publication in the country’s Official Gazette.

 

Last Update: 2021-10-21

On the 7th of September, 2021, the Chemical Registration Centre in China upgraded its hazardous chemical substance registration platform based on the module of ’Platform + Application’ mentioned in its 2021 working plan. The system was upgraded to enable companies generate Quick Response (QR) codes for hazardous chemicals.

This upgrade is meant to support the supervision of chemicals, create a better information system, and control hazardous chemicals. Therefore, the system now has a ‘one company, one product, one code’ for hazardous chemicals, and companies can now quickly generate QR codes for their hazardous chemicals.

Companies can either place their QR codes on the outer packaging and containers or on the

Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The new updated system has the following two achievements:  

  • The new platform has integrated certain functions for enterprise-end  

The functions integrated are safety data sheet registration, printing function for relevant documents, and regulation check.  

  • Guangdong was elected for a pilot test of the new system  

To identify the steadiness and reliability of this system, the Emergency Department of Guangdong Province cooperated with the Chemical Substances Registration Center to conduct a pilot. Since July 20, 2021, 1,329 companies have used the platform, which is 85.03% of the total chemical companies in Guangdong. The number of registered companies for hazardous chemicals has also increased from 229 to 495.

The use of the new system is not yet mandatory for all chemical producers, importers, and exporters. Chinese manufacturers and importers can use the new system while foreigners are required to facilitate Chinese importers with documents’ submission. However, it is predicted to become mandatorily promoted, and related regulations will be formulated in the near future.

Last Update: 2021-10-27

On the 15th of September 2021, Chinese authorities approved a list of chlorofluorocarbons (CFCs) and hydrofluorocarbons (HFCs) in agreement and under the control of the Kigali Amendment. This is an amendment to the UN’s Montreal protocol calling on developed countries to gradually phase out HCFs to reduce emissions and protect the ozone layer.

The final list, same as the draft revised list published in August, contains more than 100 CFCs and HFCs and companies have to start phasing them out. This came into force immediately after its publication.

These substances are used as refrigerants, solvents, fire suppressants, foam blowing agents, aerosols, and propellants. HFCs are widely used alternatives for HCFCs and CFCs, ozone-depleting substances which are controlled under the Montreal Protocol. HFCs have high global warming potential, hence the reason for the Kigali Amendment aiming to reduce the use of HFCs as well.

The revised list (in Chinese) can be accessed here.

Last Update: 2021-10-21

National Institute of Environmental Research (NIER) in South Korea updated the list of low-risk biocidal substances, which can be exempted from K-BPR, on Sep 27th. There are 4 low-risk biocidal substances added to the list: CAS 56-81-5, CAS 144-55-8, CAS 471-34-1, CAS 7647-14-5. With this update, there are 23 low-risk biocidal substances to be exempted from K-BPR.

This update came into effect immediately.

Attahced is the list of low-risk biocidal substances (Source: NIER).

Peru and Rwanda wrote a draft resolution on the 2nd of September 2021, to address harmful substances in plastics.  

The draft resolution requests that an intergovernmental negotiating committee be established to legally bind the treaty on plastic pollution. So far, 120 countries support the resolution and if accepted, this resolution will address the use of compounds, additives, and harmful substances in designing plastics. This also includes microplastics. 

The draft includes the following proposals: 

  • To address product design and use, this includes compounds, additives, harmful substances, and intentionally added microplastics. 
  • To achieve sustainable production and consumption of plastics which includes the uptake of secondary and alternative raw materials. 
  • To consider the need for a financial mechanism to support the implementation of priorities and the option of a dedicated multilateral fund.  

Plastic makers have shown commitment to increasing constructive engagement with governments and other stakeholders in promoting a circular economy. 

The American Chemistry Council (ACC) is very committed to eliminating plastic waste. Some NGOs have shown skepticism about it, saying ACC should not only support a global agreement but should also focus on reducing virgin plastic production and the establishment of a non-toxic, safe circular economy.  

The draft resolution will be discussed and voted on in Nairobi at the next UNEA session in February 2022. About 30 countries, including the UK and 27 EU member states, are co-sponsoring the motion to open formal talks.

Last Update: 2021-11-02

Certain amendments were proposed to the 8th version of GHS at the 10th session of the "Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labelling of Chemicals" held on the 11th of December 2020.

The new GHS document ‘version 9’ adopted these amendments, and the main updates are listed below: 

Chapter 2.1 on explosives has new updates to address explosion hazards better when they are not in their transport configuration; (pages 41-50). The new changes include further information on:

  • the classification of explosives as substance, mixture, or article
  • the minimum level of packaging you can retain an explosive until use
  • the substances and mixtures excluded from the class of explosives (2.1.1.2.2)
  • the classification criteria (2.1.2) are now tabular for a clearer understanding of Categories 1 & 2 and their sub-categories.

Decision logics are revised on pages 46 to 48 to include images on:

  • Decision logic for categories of explosives
  • Decision logic for sub-categories of explosives

There is also a revision of the classification and labelling summary tables in Annex 1. The change of classification criteria in chapter 2.1 was reflected in the table, changing the Explosives GHS hazard category from Division 1.1-1.6 to 1-2c. This can be found on pages 245-259.

Other revisions in the new version include further rationalization of precautionary statements and an update of references to OECD test guidelines for chemicals testing in annexes 9 and 10 (pages 519-524 & 535).

Download the GHS Version 9 

 

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