GPC Newsletter Apr-2022

Per- and poly-fluoroalkyl substances, mostly referred to as PFAS, are part of Persistent Organic Pollutants (POPs) present in diverse consumer and industrial products. PFAS has a myriad of applications due to its increased resistance and durable characteristics. In fact, durability is the reason such chemicals are also referred to as "forever chemicals".

PFAS are substances with fluorinated atoms, which prevent the substances from being broken down and decomposing in the environment. On the contrary, PFAS bioaccumulates in organisms, and its toxicity increases over time. Consequently, organisms may present several dysfunctions during their lifetime, and ultimately lead to death. Due to the severity and difficulties of a single country controlling POPs pollution alone, the United Nations Environment Programme (UNEP) proposed an international treaty to eliminate or restrict the production and use of POPs – the Stockholm Convention.

Recently, the United States (US) Environmental Protection Agency (EPA) published the PFAS Strategic Roadmap: EPA's Commitments to Action 2021-2024, aiming to improve research, restriction, and remediation of polluted sites. However, the agency’s definition of PFAS substances in the National PFAS Testing Strategy differed drastically from the expected common description.

When US EPA refers to PFAS substances as those "chemicals with at least two adjacent carbon atoms, where one carbon is fully fluorinated and the other is at least partially fluorinated", it includes around 7 thousand substances. On the other hand, other comprehensive PFAS definitions, such as those used by the Organisation for Economic Co-operation and Development (OECD), lead to expressive higher numbers.

The difference is that OECD opted to consider PFAS as any substance containing a fully or partly fluorinated carbon chain. This opposing view on PFAS substances may be related to recent reports showing regions along the US highly contaminated with the substance. The most recent example occurred in North Carolina, where the drinking water supplies were contaminated with dozens of fluorochemicals.

Since POPs (and all chemicals under the term) are chemicals with high persistence, durability, mobility, and toxicity, it is fundamental that authorities reach a consensus to safeguard and protect the environment and human health, nationally and internationally.

The EU has announced that the ban on Per- and Polyfluoroalkyl Substances (PFASs) will not include the essential use criteria. This is because the essential use criteria will not be ready at the right time for the restriction proposal. The essential criteria are expected to be agreed on by the end of the year whereas the PFASs restriction process has already started.  

Due to these different timelines, the strategy to ban all uses of PFASs expect the essential use criteria will still be adapted. However, the restriction proposal will rely on existing tools to analyse the substances within this category to determine if there are safer alternatives or not, thereby determining if such substance use is essential or not. 

Due to the dossier’s complexity, the submission of the joint restriction proposal by Netherlands, Germany, Sweden, Denmark, and Norway has been postponed to January 2023, giving them a six month extension. Also, the ban’s implementation may be pushed back from 2025. 

Regarding the restrictions that are already in place for specific PFASs such as the ones used in firefighting foams, and the ones banned in persistent organic pollutants (POPs) Regulation, the Commission will decide if these existing restrictions are to be separate or merged with the universal restriction.  

The European Commission recently added five SVHCs to the authorisation list, REACH Annex XIV due to their reprotoxic, carcinogenic or endocrine-disrupting properties. 

These substances include:

1. tetraethyl lead,
2. 4,4'-bis(dimethylamino)-4"-(methylamino)trityl alcohol with ≥ 0.1% of Michler's ketone or base,
3. reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) with ≥0.1% w/w 4-heptylphenol, branched and linear (4-Hbl)
4. 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia4-stannatetradecanoate (DOTE)
5. reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4- octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE)

This amendment to Annex XIV is expected to take effect from April 28, 2022. For transitional arrangements, industry has till November 1, 2023, to apply for their use authorisation. Furthermore, these five substances are prohibited from market placement and use from May 1, 2025, except for companies that are granted authorisation.

On the 29^th of March 2022, the European Commission opened a public consultation for the Cosmetic Products Regulation (Regulation (EC) No 1223/2009).

The objective of this revision is to ensure human health and improve the functioning of the internal market. It will focus on four key points:

• The use of nanomaterials in cosmetics and their definition
• The application of a generic approach on risk management (GRA) to ensure that cosmetics do not contain CMRs (carcinogenic, mutagenic, or toxic for reproduction) substances, or substances that affect the endocrine system (endocrine disruptors) or are persistent and bioaccumulative.
• Reattributing assessments of substances used in cosmetics to be lined-up with the Scientific Committee on Consumer Safety (SCCS)’s approach: “one substance, One assessment”.
• Simplification and the digitalisation of the labelling requirements.

In its preliminary assessment, the European Commission expects positive impacts in various aspects such as economy, social, and environmental. Moreover, the revision of the Cosmetic Product Regulation could have positive effects on administrative burden as it aims to harmonise the different chemical legislations and simplify the processes of compliance checks of the products.

The consultation will close on the 21^st of June and the following stakeholders are welcome to contribute to the consultation: Citizens and consumers, Professional users of cosmetic products, Manufacturers, Importers, Distributors, and other businesses (SME, Industry and SME associations, civil society organisations, member state authorities, market surveillance authorities, customs authorities, any other interested stakeholder).

In March, the European Commission adopted REACH authorization decisions for the use of four chemicals that are listed in Annex XIV of the law.

CTPht is on the REACH authorization list for its carcinogenic, persistent, bioaccumulative and toxic (PBT), and very persistent, very bioaccumulative (vPvB) properties. And 4-tert-OPnEO and 4-NPnEO are on the list for their endocrine-disrupting properties when they degrade which affects the environment.  

However, the Commission rejects two authorization requests for the use of CTPht as a binder in producing clay targets. The reason is that the application did not show if and how the socio-economic benefits outweigh the risks to human health and the environment. Check the table below for the substances that have review dates.

The European Commission published, on April 25, 2022, a list of substances and substance groups for which restrictions under the REACH Regulation are being proposed, prepared, or considered.

One of the lines of action under the European Union Chemicals Strategy for Sustainability is the coordination and prioritization of restriction proposals. After a process involving all the relevant authorities (the Commission, ECHA, and Member State Competent Authorities), the newly published “Restrictions Roadmap under the Chemicals Strategy for Sustainability[DT1] ” provides an overview of the different substances being considered for restriction.

The Roadmap establishes a Rolling List of substances for restriction, which categorizes proposals into three groups:

1. Restrictions for which formal procedures have already started
2. Restrictions on which preparatory work has been done, but haven’t been formally proposed yet
3. Restrictions (or revisions of restrictions) that are being discussed as one among other management options

In addition to the status of restriction proposals, the Rolling List contains information on the uses covered by the restriction and a tentative date for the submission of the restriction dossier.

The Rolling List is not legally binding. Therefore, substances included might not be proposed for restriction eventually, and – conversely – restrictions may be proposed for substances not included. To preserve clarity and predictability, it will be updated regularly to reflect the decision making status on restrictions.

GPC is closely observing developments in relation to the EU’s Chemicals Strategy for Sustainability. Download our latest Regulatory Summary of EU Chemical policies to stay updated. 

You can also download the roadmap here.

The Department for Environment, Food and Rural Affairs (DEFRA), UK in March 2022 published guidance for data and information sharing of the same chemical substance. This guidance will help companies and individuals understand their obligations pursuant to UK REACH.

This applies to anyone who manufactures or imports chemical substances over one tonne per year into Great Britain. During substance registration, registrants who register the same substance have to jointly submit information to avoid repeated studies, and unnecessary animal testing and to reduce costs. These joint registrants are matched to a substance group where the substance group members are expected to share details like registration strategy, cost-sharing model, and data.

This published guidance states that members must share study summary data (about available studies, data gaps, and publicly available data) for joint registration submission. If a new member joins, they can request any study summary data from existing members, if needed for registration. However, if the summary data involves vertebrate animal testing, the information has to be requested. And members must agree on how to meet information requirements for their joint registration when the study is not yet available. 

Group members should agree on how to share the costs for existing and new studies, and appoint a lead registrant. The lead registrant holds the responsibility of submitting the lead joint registration dossier and approving members into the joint registration group. This role can be claimed once the lead dossier is ready to be submitted. Furthermore, members will also submit their member dossier, which should provide information about the manufacture and uses of the substances they are registering.

The guidance also includes information on the grounds based on which members of the substance group may trigger a data-sharing dispute. Accordingly, such disputes may be initiated when:

• a data owner refuses to provide details of the costs of study summary data or a copy of a study summary
• there’s a failure to reach an agreement about data sharing

Disputes may only be initiated if the members submit evidence that they have tried to reach an agreement in good faith.

Lastly, the guidance provides that group members can opt-out of a joint data submission partially or fully under certain conditions like:

• If it is costly for you or your company
• If there is a disagreement when selecting what to be submitted in the lead dossier
• If it discloses sensitive information that might cause commercial damage

There must be a justified reason when opting out of joint registration which will be submitted alongside your member dossier.

The Bureau of Indian Standards (BIS) has granted licences to 661 domestic toy manufacturers after determining that they comply with a 2020 quality control order that limits the use of certain heavy metals, phthalates, and flame retardants. Companies must apply to the standards bureau and allow its auditors to inspect manufacturing facilities and test product samples to obtain a licence. If they are granted a licence, they must then purchase a quality certification logo demonstrating that their products do not exceed the limits for restricted substances specified in Indian Standard (IS) 9873.

Licences are valid for one year and can be renewed subject to additional inspections. Anyone found in violation of the Quality Control Order (QCO), which went into effect on January 1, 2021, faces up to two years in prison and a minimum fine of 200,000 Indian rupees ($2,627). According to a press release issued by the Ministry of Consumer Affairs, Food, and Public Distribution on April 6, 630 – or 95 percent – of the licences granted were to small and medium-sized businesses.

The Food Safety and Standards Authority of India (FSSAI) amended the Food Safety and Standards (Packaging) Regulations 2018, allowing for the use of recycled plastics in food contact materials (FCM) with certain restrictions. The update clarifies the ambiguity caused by an amendment to India's plastic waste management rules published last September. The amendment permitted the use of recycled plastic in FCMs, in contrast to the 2018 packaging regulations, which prohibited its use. The amendment serves as a stopgap measure until the draught Food Safety and Standards (Packaging) Amendment Regulations 2022 are completed. However, it is unknown how long it will take for the new legislation to take effect.

In 2016, the Food Safety and Standards Authority of India prohibited the use of recycled plastics in food contact. The recent change has "shocked experts and environmental activists," according to The Times of India. According to Vijay Habbu of the Institute of Chemical Technology, when a plastic product is recycled, "there is some degradation of the plastic with the generation of contaminants or impurities." Most of the time, the contaminants are unknown. As a result, there are no reliable test methods for detecting and determining impurities that can seriously endanger human life and the environment."

As part of its drive to use safer alternatives, India has imposed restrictions on certain hydrofluorocarbons (HFCs) and ozone-depleting substances (ODSs), requiring importers and exporters to obtain government permission before trading.

The new rules, which were introduced as amendments to India's existing HFC export and import policies, went into effect on March 9 for importers and March 23 for exporters via Directorate General for Foreign Trade (DGFT) notifications. Before entering into agreements with overseas buyers or suppliers, domestic HFC and ODS manufacturers, exporters, and importers must obtain "no objection certificates" (NOCs) from the Ministry of Environment, Forests, and Climate Change (MoEFCC). In August of last year, India ratified the Kigali Amendment to the Montreal Protocol on Substances that Deplete the Ozone Layer, committing to an 85 percent reduction in HFC production and consumption by 2047. According to a MoEFCC spokesperson, the international trade restrictions are intended to "align domestic HFC user industries with the government's goal of reducing use of the substances and a gradual shift to the use of alternatives."

The Bureau of Indian Standards (BIS) is holding a consultation process until May 11 on a proposed amended standard for ready-mixed paint, air drying, and red oxide-zinc chrome priming, which would extend lead content limitations in place for domestic purposes to the industrial sector. Lead, lead compounds, and lead combinations would be limited to no more than 90 parts per million (ppm).

This is currently set at 1,000ppm for industrial use and 90ppm for domestic use. To eliminate consumer confusion and raise attention to the health and safety risks linked with lead, a BIS technical committee has proposed a "unified single allowable level."

The draft establishes material standards, as well as the sampling and testing techniques. It is used "as a primer in the enamel painting system for metal surfaces and also to keep steelwork in good shape for home and decorative purposes, as well as in coastal and inland outdoor environments." says the BIS. If approved, Indian Standard (IS) 2074 for ready-mixed paint, air drying, red oxide – zinc chrome, priming – specification' will be revised for the fourth time. In addition, the draught suggests quantities for substances utilised in its production, such as:

• Minimum zinc chrome content of 16 percent by mass, 6.88 percent by mass chromic anhydride content, and zinc oxide content of 5.84 percent by mass;
• minimum synthetic red oxide or natural red oxide content of 50% by mass.

The official draft document can be accessed here

The National Institution for Food and Drug Control of China (NIFDC) published the draft revision of “Safety and Technical Standards for Cosmetic” (Safety Standards) on March 31, 2022. This is the first-time revision of the Safety Standards since the first version was published in 2015.

The Technical Standards form part of the overarching framework of NMPA’s Cosmetic Supervision and Administration Regulation (CSAR). All cosmetic ingredients’ manufacturers must make sure that their ingredients comply with the requirements listed in the Technical Standards.

As of now, there are 7 lists in total in the 2015 version. They regulate different areas in using cosmetic ingredients, including banned and restricted ingredients in general, allowed ingredients in sunscreen, preservatives, colorants, and hair dyes in cosmetics.

The revision remains the structure of the 2015 version, while it makes changes in the following parts:

• Adjusted the application scope of restricted or limited cosmetic ingredients. The number of banned ingredients will increases from 1388 to 1393, while the number of restricted ingredients decreases from 47 to 44.
• The number of allowed ingredients is also adjusted in different sectors. There are 48 permitted preservatives in the revision which is down from 51. The number of approved sunscreens and colorants are 26 and 156 respectively, which are all down by one compared to the 2015 version. Currently, the available hair dyes are 73 which is down by two.
• It is also clear from the revision that NIFDC will not permit the use of preservatives containing mercury or mercury compounds.
• 10 physical and chemical inspection methods are excluded from the newly revised version. There will only be 67 approved methods for conducting physical and chemical inspections if the revision is adopted.
• However, eight more toxicological test methods are added. The total toxicological tests amount to 24.
• The number of efficacy evaluation tests also increased from three to five.
• There is an upgrade to the requirement for safety assessment reports in line with cosmetic registration procedures under CSAR.

The consultation period will last until April 30, 2022. If you have any considerations regarding the revision, you can contact GPC via email: compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com or via GPC WeChat: 46 0708381983 (GPC China) for information and help.

The Ministry of Environment (MoE) in South Korea is consulting on a draft amendment of Designation of Toxic Substances under Enforcement Decree of the Act on Registration and Evaluation of Chemicals (K-REACH).

The draft amendment mainly proposes revisions including:

• New designation of toxic substances for which hazard reviews has been completed (from 2022-1-1099 to 2022-1-1109)
• Update details of toxic substances (35 substances)
• Regulate import declaration and business license for newly designated toxic substances, and transitional measures of labeling and handling standards for hazardous chemical substances

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

The deadline of this consultation is May 9th, 2022.

The National Institute of Environmental Research (NIER) in South Korea updated the regulation on the scope and methods of biocidal substances and biocidal product approval application data under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR) on April 8th, 2022.

The scope include:

On March 23, 2022, the Department of Agriculture, Water and the Environment, Australia, published a roadmap for IChEMS and a draft of IChEMS principles is now available for public consultation until May 24, 2022. IChEMS is a national approach in Australia to help industry and governments manage the environmental risks of chemicals. It also aims to facilitate industry to choose less harmful chemicals. The legal basis of IChEMS is the legislation ‘Industrial Chemicals Environmental Management (Register) Act 2021’ that was passed in March 2021.  

The introduction of Australian Industrial Chemicals Introduction Scheme (AICIS) in 2019 presents a new scheme for industrial chemical management in Australia. AICIS is responsible for regulating the import and manufacture of industrial chemicals in Australia and assessing risks to human health and the environment across the lifecycle of industrial chemicals. IChEMS operates closely with AICIS, including using AICIS risk assessments to schedule industrial chemicals on the IChEMS Register (a record of chemical scheduling decisions made under the Industrial Chemicals Environment Management (Register) Act 2021).

Earlier in the month, the Australian Government, Department of Health, has shared a complete list of chemicals on the Inventory. This downloadable inventory was updated till 10 February 2022 and the next update would be released in late 2022. The inventory contains around 40,000 chemicals that are being manufactured or imported (introduced) into Australia for industrial use.

In the initial plan published last year on IChEMS, companies importing or manufacturing chemicals were expected to pay the fee for IChEMS register from September this year. This will be delayed for a year from September 1, 2023. The fee structure will be announced after industry consultation in late 2022.

After the public consultation, the plans for IChEMS implementation can be expected from June 2022. In late 2022, the authorities plan to incorporate IChEMS Register into the regulatory framework and realize IChEMS vision and goals from 2023.  

GPC has a legal entity in Australia and can help non-Australian companies to meet their compliance requirements as an Australian agent

On April 14, 2022, the Brazilian government approved the National Solid Waste Plan previously foreseen by the National Solid Waste Policy of 2010. Their main objective is to support solid waste management and planning in federal, state, and municipal spheres.

After 12 years, Decree 11043 of 2022 plans for long-term development. Within its 20 years’ timeframe, the National Solid Waste Plan is divided into phases. Initially, the urban waste is diagnosed nationally, contemplating the national and international best practices addressing the issue.

New mechanisms are supporting the compilation of information and population awareness. This is the case of the National Information System on Solid Waste Management (SNIR), displaying legal text, regulations, waste generation characteristics, reverse logistics schemes (Extended Producer Responsibility - EPR), reports, and on.

Among the main goals, the following are highlighted:

• The elimination of dumping places until 2024
• Until 2040, recover at least 48% of the generated mass (recycling, energy, and biologic waste)
• Until 2040, 95% of municipalities will offer a formal contract for cooperative and waste collectors
• Recover 50% of all packing material through reverse logistics in 2040
• Highly improve energy generation on varied decomposing waste sources, benefiting more than 27 million households
• Recycling 25% of waste from civil construction until 2040

The National Solid Waste Plan will be updated every four years to assess progress in diverse sectors and evaluate investment gaps. Businesses in Brazil shall pay close attention and assure compliance with the provisions.

The national solid waste plan can be viewed here.

In Brazil, the Globally Harmonized System (GHS) of classification and labeling is established by the Brazilian National Standards Organization (ABNT) standard and officially implemented by Regulatory Norm (NR) 26. Currently, chemical classification and labeling in Brazil follow the GHS 5^th revision.

ABNT proposed updating the GHS version utilized in Brazil and its requirements. Currently, there are two projects under public consultation for this purpose. First, ABNT made available a draft document proposing to update general aspects of the GHS, classification, safety data sheet (SDS), and labeling of chemicals – called ABNT 14725 revision. Accordingly, ABNT also proposed to bring up-to-date the requirements of hazardous chemical residues, referred waste SDS, and related labeling under ABNT 16725 revision.

In addition to updating exigencies and modifying the national standard to the GHS 7^th revision, ABNT aims to consolidate the reference into a single document – which today is distributed among four different standards. Both revision projects are in the second stage and open for public consultation until April 28, 2022.

Interested parties may express their concerns via the ABNT official website until the referred date. The final version and publication are planned for September 2022.

Colombia officially joined the Organisation for Economic Co-operation and Development (OECD) in April 2020 despite not complying with all instruments required by the organization at the time. In this respect, Colombia has been working to develop post-accession mechanisms since then.

In a recent OECD report, the organization complemented Colombia for its progress towards the remaining instruments. Out of 75 required OECD instruments, Colombia joined the organization with 22 lacking/partially covered implementation gaps and 11 involving chemicals. Over these two years since Colombia's ascension, the country advanced 17 environmental commitments already approved by OECD.

Panning to the chemical sector, Colombia has advanced on nine out of 11 compulsory instruments. This involves the recently adopted national framework for chemicals enacted by Decree 1630 in November 2021, becoming the second country in Latin America to present solid guidelines for chemicals.

Decree 1630/2021 targets hazardous substances for industrial use identified by the Globally Harmonized System (GHS) of classification and labeling. The production, import, use, marketing, distribution, and transportation activities are requested to comply with the provisions. Consequently, manufacturers or importers of chemical substances over 100 kg per annum are required to submit information to the authorities. This information includes:

• Manufacturer or importer information
• Substance amounts manufactured or imported
• Substance identification, including CAS number
• Substance hazard classification in accordance with the GHS
• Identified substance uses

Decree 1630/2021 also establishes the national inventory of chemicals substances, imposes prioritization and risk evaluation on certain substances, requires risk reduction and management programs, and improves environmental and health chemical monitoring.

Peru has been working on its national chemical policy at least since 2020. In recent months, Peru approached the United Nations Environment Programme (UNEP) for funding its implementation and enforcing mechanisms.

UNEP has been holding a special Chemical and Waste Management Programme since 2015 to support countries in developing effective frameworks for legislation and regulations addressing chemicals. Overall, the Programme has already funded projects in 57 countries worldwide.

Peru has filed a project request with a 30-month duration and financing of around 250 thousand dollars. In return, the country will disburse 134 thousand dollars, totaling about 384 thousand dollars. Peru is successfully expected to develop, adopt, monitor, and enforce the necessary activities to bring the national chemical legislation into practice with this amount.

In June 2020, the Ministry of Health drafted the sound national chemical management bill which was submitted for public comments until September 2020.  The Regulation and Control of Dangerous Substances proposes to classify and sort substances according to the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals, to create a national register of chemicals, to impose substances to health and environmental assessment, and provide risk management measures for hazardous substances. In addition, Peru intends to implement a certification for those who deals with chemicals (called sanitary authorization), which would have to be renewed every three years.

Another relevant point is the recent Organisation for Economic Co-operation and Development (OECD) discussion to evaluate Peru's membership. In Latin America, OECD plays a crucial role in developing each country's chemical regulations; for example, Chile and Colombia are the only countries in the region that have adopted comprehensive chemical regulations – and have actively participated in the organization since 2010 and 2020, respectively.