GPC Newsletter Jul-2022

A ground-breaking prohibition on per- and polyfluoroalkyl substances (PFAS)-containing clothing has been approved by the New York legislators, which will enter into force next year upon being signed into law by the governor.

It is expected to facilitate a far-reaching market shift against PFAS in most garments and to expand on the momentum to restrict the persistent substance class across consumer goods in New York and other US states by enforcing the bill (S 6291A/A 7063A).

There is at the same time another similar measure (AB 1817) that covers textiles more broadly clearing California’s state Assembly, while some advocates in New York are working their way to promote several more proposals so as to eliminate PFAS applications in the legislature’s final days.

The already approved PFAS-containing apparel ban would halt the sale of the following articles with deliberately added per-and polyfluoroalkyl substances by December 31, 2023: shirts and tops, pants, skirts and dresses, vests, normal attire, leisurewear, underwear, scarves, onesies, bibs, and diapers.

The professional uniforms and heavy-duty outerwears are excluded from the ban, while PFAS-containing carpets and rugs have already been banned in early May as part of a larger extended producer responsibility measure (S 5027C/A 9279A), which, upon signed into law, shall take effect on December 31, 2024.

One critical factor for the approval here is that PFAS, though providing textiles with extraordinary durability and maintenance of apparel, are in general deemed non-essential in textiles, in which case famous retailers such as Gap Inc., Levi Strauss, and Patagonia, etc., have long pledged to move away from applying such compounds in their products. Nonetheless, the American Chemistry Council (ACC) urges to launch a veto against this decision, intending to demonstrate the negative consequences such a ban would have on consumers.

Noteworthily, the involved lawmakers plan to release a new measure targeting various goods, addressing textiles, fabric treatments, cookware, ski waxes, cleaning items, and architectural paints in reminiscence of multiproduct legislation awaiting executive action in Colorado. Further laws eliminating additional categories of PFAS-containing products before the legislature adjourns on June 2 are also pressed by several other environmental NGOs and legislative sponsors in New York. In the meantime, another bill (S 3331A/A 143) prohibiting PFAS and other concerning substances in cosmetics is also in the process of vigorous discussion.

The US Environmental Protection Agency (EPA), on July 4, 2022, notified its draft revision to the Toxic Substances Control Act (TSCA). This is for risk determination for Perchloroethylene (PCE) risk evaluation to reflect the announced policy changes by ensuring the public is protected from unreasonable chemical risks.

According to the draft, the US EPA after evaluation of use finds PCE as a toxic chemical substance that presents unreasonable risks to health. Although this evaluation does not consider the assumption of workers appropriately wearing personal protective equipment (PPE).

When the decision becomes final, it will override the condition of use-specific no unreasonable risk determinations in the December 2020 PCE risk evaluation and make a revised determination of unreasonable risk for PCE as a whole chemical substance.

The final date for comments on the draft revision is August 1, 2022.

The US Environmental Protection Agency (EPA) publishes new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances that are subject to premanufacture notices (PMNs).

This new rule means that concerned persons have to notify EPA at least 90 days before manufacturing or import takes place. It also applies to processing any chemical substance under TSCA for an activity that is tagged as significant new use by the new rule. Therefore, concerned persons cannot comment manufacturing or processing of chemicals for the significant new use until they have submitted a Significant New Use Notice (SNUN) and EPA has made the notice determination, which comes after reviewing the notice.

The new rule will come into force on August 26, 2022, after its promulgation on July 11, 2022.

On the 11^th of July 2022, the Environmental Protection Agency (EPA) in the US notifies and seeks comment on a draft revision for trichloroethylene (TCE) risk evaluation issued under TSCA.

The old draft was revised to reflect the policy changes, to enhance the environment’s protection from unreasonable risks caused by chemicals. According to EPA, TCE as a whole chemical substance can cause unreasonable risks and injury to health.

This decision does not cover the assumption that all workers always wear personal protective equipment (PPE). This is because there is possibly a subpopulation of workers who might be highly exposed to TCE because they are not covered by OSHA standards or because many of OSHA’s chemical-specific permissible exposure limits are now outdated and inadequate for protecting workers’ health. OSHA standards are the rules that explain the methods employers are obligated to use to ensure their employees are protected from hazards.

When implemented, this decision will supersede the condition of use-specific no unreasonable risk determinations in the November 2020 TCE risk evaluation and will make a revised determination of unreasonable risk for TCE as a whole chemical substance.

The proposed dates of adoption and entry into force are yet to be determined. Comments for the draft revision will close on August 8, 2022.

On June 22, 2022, the European Commission opened a consultation period for proposed amendments to Annex VI of Regulation 1272/2008 on Classification, Labelling, and Packaging of substances and mixtures (The CLP Regulation).

Annex VI of the CLP Regulation relates to harmonized labelling and classification of most hazardous chemicals. Part 3 of said Annex lists the substances subjected to harmonization, including, for instance, their hazard class and category, hazard statements, pictograms, and signal words. Harmonized entries also contain references to a list of notes that seek to provide further clarity on the obligations applicable to any given substance. Notes are drawn from a list of notes that can be found in Part 1 of the same Annex, and they can refer to the classification and labelling of either substances or mixtures.

The Commission is currently consulting on the addition of three additional notes to the overall list of notes. One of the new entries would relate to the classification of substances, and it would clarify that where harmonization entries relate to a group of substances, they only apply to the part that said substances have in common. The remaining two proposed entries relate to the calculation of the relevant thresholds for the classification of mixtures as reproductive toxicants in some specific cases.

Public consultation is open until July 20, 2022. The proposal is for a delegated act within the CLP Regulation, which empowers the Commission to adapt specific provisions to technical progress. Delegated acts benefit from a quicker adoption procedure: once the Commission adopts its proposal (after taking public contributions into account), it will automatically become law after two months unless Parliament or Council explicitly object.

The European Chemicals Agency (ECHA) releases a new SCIP Candidate List package to align with the inclusion of more substances on the Candidate List. This will help companies to create SCIP notifications that include the new substances.

The IUCLID reference substance approach is needed when providing information about Candidate List substances in your SCIP notifications. Although reference substances can be created in IUCLID, ECHA recommends the use of their pre-made SCIP package which for instance can then be imported to IUCLID.

Previously, the SCIP Candidate list was updated on July 2021. For SCIP notifications, the new candidate list reference substance package includes:

• Individual reference substance datasets
• A change log of the candidate list package
• Delta package reference substance datasets
• A list of reference substance

SCIP is the database for information on Substances of Concern In articles as such or in complex objects (Products) established under the Waste Framework Directive (WFD). Companies supplying articles containing substances of very high concern (SVHCs) on the Candidate List in a concentration above 0.1% weight by weight (w/w) on the EU market have to submit information on these articles to ECHA.

The Candidate List of substances of very high concern now contains 224 entries as one substance N-(hydroxymethyl)acrylamide (CAS No. 924-42-5) has been added on June 2022. Before this, the Candidate List of substances of very high concern was updated on January 2022 which consisted of total 223 (219+4) entries as four new substances were added:

• 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol (CAS No. 119-47-1)
• tris(2-methoxyethoxy)vinylsilane (1067-53-4)
• (±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one covering any of the individual isomers and/or combinations thereof (4-MBC)
• S-(tricyclo(5.2.1.02,6)deca-3-en-8(or 9)-yl O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate (255881-94-8).

Companies are responsible for managing the risks of these chemicals and must also give their customers and consumers enough information to use them safely as these can harm people or the environment.                                                                                                                                  

On July 1, 2022, the European Commission published a guidance document addressing the relationship between the REACH Regulations and the EU sanctions recently imposed under Council Regulations 269/2014 and 833/2014.

The new document explains that data owners cannot engage in negotiations for data sharing and other transactions with a person who is appointed under Council Regulation 269/2014 or owned/controlled by an appointed person under the regulation on ‘Sanctions adopted following Russia’s military aggression against Ukraine’. All ongoing negotiations are expected to be suspended. Also, companies or groups of companies who entered into agreements with other companies before designation under Council Regulation 269/2014 or owned/controlled by an appointed person under the regulation should take all necessary actions while considering the business operations and current agreements.

Funds cannot be sent to someone who is appointed/designated under Council Regulation 269/2014 or owned/controlled by an appointed person under the regulation. Such funds can be in an escrow account and ECHA will get involved if there is a disagreement.

Under Council Regulation 269/2014, lead registrants should be changed. Also, lead registrants cannot submit information and dossier updates for persons that are designated under the regulations. Furthermore, only representatives cannot represent anyone appointed/designated under Council Regulation 269/2014 or owned/controlled by a designated person under the regulation. The full guidance document can be accessed here.

The Helsinki Chemicals Forum held from June 8 to 9, 2022 was a great success, from which key highlights of the industry were discussed brilliantly. This is a hybrid event, a first of its kind and there were more than 200 international policymakers, industry representatives, NGOs and academicians who attended the event.

Some of the discussions centred around the need to accelerate chemical regulations, to define sustainable by design chemicals, to merge chemical risk management with circularity and climate policy objectives, to speed up the replacement of animal testing, and the role of a global science-policy interface panel.

The session on the integration of chemical risk management with circularity and climate policy objectives was moderated by Steve Van de Broeck, the director of REACH and Chemicals Policy, Cefic. This is called the 3Cs and it is aimed at helping the EU meet the EU Green Deal goals. This integration is possible but would not be a smooth one due to conflicting and competing interests such as short and long-term benefits and differences in environmental aims.

Following the panel discussion on replacing animal testing, there is a consensus that there is a need to replace animal testing and most regulations are now tilting towards its replacement. Animal testing is time consuming, expensive, and sometimes not accurate to speculate the chemical effects on humans. Although new approach methods (NAMs) are coming up, their implementation is slow and most regulatory bodies need assurance that these NAMs are as effective as the use of animals for testing.

Also, NAMs are more readily available for endpoints such as aquatic toxicity and genotoxicity which is not the same for the more challenging endpoints such as carcinogenicity, immunotoxicity, and endocrine disruption.

A key update regarding animal testing is the project set up by the European Partnership for Alternative Approaches to Animal Testing (EPAA). The project ‘Use of NAMs for regulatory decisions on chemical safety’ has workstreams that are studying the application of NAMs within the industry.

The full report can be accessed here.

On 29 June 2022, the European Commission published its draft agenda for the second half of 2022. The agenda contains the meetings to take place between July and December 2022. Approval of a text at a joint meeting of all Commissioners is the last step for the Commission to formally adopt it as a proposal. Therefore, the topics to be discussed in meetings are an indication of what files the EU executive is expecting to advance on.

In relation to chemicals legislation, two key proposals are mentioned in the draft agenda. First, the revision of Regulation (EC) 1272/2008, on the classification, labelling and packaging of substances and mixtures (the CLP Regulation) will be discussed in late October according to the schedule. Second, new rules on intentionally added microplastics will be discussed in late November.

If progress on both initiatives aligns with these timelines, negotiations between the Parliament and the Council on these two key initiatives would be an important part of the legislative agenda in 2023.

Another key piece of legislation when it comes to chemicals – the revision of Regulation (EC) 1907/2006, concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) – is not mentioned in the agenda. This could signal that it will be delayed and presented in 2023.

This would be consistent with the fact that, while all three initiatives have seen delays relative to their initial expected timelines, the CLP review and the microplastics proposal are more overdue than the REACH revision.

On 22 June 2022, the European Commission adopted a proposal to revise Directive 2009/128/EC on the sustainable use of pesticides. Adopted in 2009, the Sustainable Use of Pesticides Directive sought to reduce the risks to human health and the environment arising from the use of pesticides in agriculture. To achieve these objectives, the Directive promotes the use of integrated pest management – a general approach to agriculture considering all available plant protection methods and techniques – and non-chemical alternatives to pesticides.

However, the implementation of the Directive in the EU Member States has been found to be insufficient to achieve its objectives. To address these shortcomings together with the consideration of the EU’s ambition in this area in line with the European Green Deal, the European Commission proposes to replace the Sustainable Use of Pesticides Directive with an enhanced regulation (which would therefore be directly applied across the European Union).

The new rules would build on the existing system by establishing binding reduction targets for the use of chemical plant protection products. These would be set at the Member State level within an overarching target of a 50% reduction by 2030 at the European level. Public authorities in the Member States would then be responsible to take measures to reduce pesticide use. An equivalent target is set for the reduction of the use of “more hazardous plant protection products” (namely, products containing active substances that have been designated as candidates for substitution under the Union’s plant protection product legislation).

In addition to the overall reduction targets, the use of all types of pesticides would be prohibited in what the regulation calls “sensitive areas” (such as public parks, gardens and paths, protected areas, or human settlements). Persons wishing to use pesticides within or near these areas would need to procure an authorisation, which may only be given where there is a “proven, serious and exceptional” risk of pests spreading and no other technically feasible alternatives are available.

Additionally, the regulation proposal contains several procedural provisions. These relate to the calculation of national targets, the drafting and implementation of national plans, the training and certification of operators involved in pesticide use, and the inspection of equipment for pesticide application.

The proposal adopted by the European Commission will now be scrutinized and debated by the European Parliament and the Council of the European Union, both of which must agree on a version that will then become law.

On July 6, 2022, at the meeting of CARACAL (the EU’s expert group bringing together the Competent Authorities for the REACH and CLP Regulations), the European Commission presented some of the options it is currently considering for the reform of the Registration and Authorisation regimes under REACH.

The revision of the REACH Regulation is one of the key ongoing processes in what comes to chemicals legislation. It is expected to address current shortcomings with the regulation’s implementation. It also seeks to bring it in line with the EU’s ambition for a pollution-free environment under the European Green Deal and the EU Chemicals Strategy for Sustainability, especially the operationalization of an “essential use” approach governing the acceptable uses of chemical substances.

Reform of the Authorisation and Restriction Regimes

Some of the key shortcomings that the review seeks to address are the slow pace, inflexibility, and overall complexity of both the authorisation and restriction procedures under REACH – which are its two main tools in what comes to phasing-out hazardous chemicals. Under Authorisation, Substances of Very High Concern (SVHCs) can generally only be used once an individual authorisation is obtained. Only the applicants for an authorisation benefit from it. Under Registration, on the other hand, general requirements for the use of specific substances are set (which all economic operators must respect).  

The Commission working paper discussed at the CARACAL meeting presented three options in relation to the Restriction and Authorisation regimes.  A first option would see the current system maintained, where substances can either be subject to Authorisation or Restriction and can be used in line with authorisations or restriction derogations.

A second option would merge authorisation and restrictions into one single system. While the procedures to identify SVHCs would remain the same, the outcome of this designation would be similar to that of restrictions (for instance, SVHCs would be included in the same Annex as restricted substances). In relation to this second option, the Commission is also deciding how the remaining possibilities for use would be established. In addition to the existing approaches (general pre-established rules and individual applications), a new possibility for authorisations benefitting all actors beyond the applicants is being considered. The new rules would apply to both SVHCs and restricted substances, which would essentially become the same group of substances.

A third and final option is to abandon the authorisation regime altogether and rely instead on restrictions as the main tool to enforce chemical legislation at the European level (complemented by national legislation).

Implementing “essential use” into EU Chemicals legislation

As regards the implementation of the “essential use” concept, the Commission restates that this implies that chemicals can only be used where they are necessary for health, safety, or the functioning of society, and where there are no acceptable alternatives. While this standard might not apply to all chemicals – the paper speaks about “the most harmful chemicals” – it clearly signals a push for more stringent chemicals regulation.

The idea of essential use would therefore be relevant when assessing applications for authorisation or when setting the general rules under restrictions. The Commission is considering several options to bring this concept into European law, ranging from the adoption of non-binding guidance to the introduction of legal changes replacing socio-economic analysis with essential use considerations.

The Commission is also considering two different procedures for this essentiality assessment. Under a first proposal, in cases where the availability of alternatives is hard to establish in a preliminary analysis by the ECHA secretariat, a committee composed of the Member States would decide on the essentiality of the use in parallel with the assessments in ECHA’s Socio-Economic Analysis and Risk Assessment Committees.  In the second option, the essentiality assessment by the Member States will be placed at the beginning of the process, and only unclear cases would be studied by ECHA’s Committee. 

While the fact that the Commission is still considering several options makes it hard for businesses to anticipate upcoming compliance implications, the options under consideration signal a commitment to advance toward the vision set out in the European Green Deal. Comprehensive chemical management and the phase-out of substances of concern is an essential part of the said vision and many of the ongoing changes point in that direction.

Published by Britain’s Health and Safety Executive, the first opinion on mandatory classifications under GB CLP aligns with the previous technical report in all 23 cases even if it hints at divergence from the EU.

In all the cases where there is potential for different classifications to those proposed in the EU, the agency found no significant impact. However, there is potential for different classifications in the case of five opinions on:

• Azamethiphos, an organophosphate insecticide currently under review as a biocidal active substance,
• Mancozeb and trifloxystrobin, two fungicides for crop use
• Cyfluthrin, insecticide approved for use as a biocidal active substance, and
• Beta-cyfluthrin, a pyrethroid insecticide for crop use.

These mandatory classifications would have impacts on moulding downstream legislation, affects if a particular product is available on the market, while the forked opinion as such can be seen from the product azamethiphos. It currently has no entry in the GB MCL list and warranted classification as a category 2 carcinogen, but the Health and Safety Executive in the UK (HSE) disagreed with this aspect of the committee’s opinion.

The disapproval of this biocidal use in the EU dwelled in the previous withdrawal of application for authorization and its use in GB is also still under review. For the other 18 Opinions, the technical reports agreed with the Echa’s Risk Assessment Committee (RAC), and the HSE plans to publish another 82 Opinions by the end of June 2022.

Under the current scheme, within six months of RAC publishing an Opinion on mandatory (harmonised) classification under EU CLP, the HSE have to publish a technical report outlining if it agrees with the scientific assessment. Concerns from many NGOs have been flourishing for this distinct UK chemicals legislation after Brexit, which bears the great potential to diverge from EU laws, and seems to pose great threats to the protection of human health and the environment.

Socio-economic factors are another point to take into consideration in the Opinion adopted by the agency on the proposed changes within 12 months of publication of the technical report, after which the HSE spends another 12 months to give feedback and suggestions on if the proposed classification should be implemented. Lastly, after all these procedures, the governors have three months to decide on the implementation of these recommended changes to the GB legislation as well as to include them in the Mandatory Classification and Labelling (MCL) list.

In June, the UK’s Health and Safety Executive (HSE) published Work Programme 2022/23 detailing the UK REACH activities carried out in the last calendar year and the activities HSE will carry out for the UK REACH operation, together with the Environment Agency and other relevant agencies.

HSE is an agency for UK REACH, mainly responsible for handling regulation functions under UK REACH.

The newly published Work Programme includes information about UK REACH activities, multiannual priorities, work plan, dossier evaluation, substance evaluation, risk management and its engagement with the wider regulatory community.

A proposed amended standard that would prohibit the use of heavy metals in dipentene, which is used to make paints, enamel, lacquers, and polishes, is being discussed by India until July 25.

The following heavy metals found in dipentene are proposed to be banned by the proposal:

• Cadmium,
• chromium VI,
• arsenic,
• antimony, and their oxides, as well as
• mercury and its derivatives.

Additionally, it states that the total amount of any of them in their natural forms or other contaminants in dipentene cannot be greater than 0.1 percent by weight. The document also suggests establishing a lead content maximum acceptable limit of 90 parts per million (ppm).

Additionally, it advises that packaging be properly sealed and stamped with the following details:

• name of the material 
• name of manufacturer and its recognised trademark if any
• mass of the material 
• lead content (maximum)
• heavy metals content 
• month and year of manufacture 
• lot or batch number and   
• relevant cautionary notes. 

Indian Standard (IS) 644 would undergo its third modification if the draft, which was released by the Bureau of Indian Standards (BIS) in May, is accepted. Products that meet its specifications would be certified by the BIS and have a conformity mark on the packaging.

On the 30^th of June, the China Solid Waste and Chemicals Management Center under the Ministry of Environment and Ecology (MEE-SCC) published a FAQ document which specified several hot debated questions for new chemical substances registration under MEE Order No.12. Below are some key questions excerpt from the FAQ document.

1. Testing institutions’ qualifications for polymer registration.

The "Guidelines for Environmental Management Registration of New Chemical Substances" has corresponding requirements for domestic and foreign testing institutions for physical and chemical properties. The testing institutions for GPC and other spectra have the same requirements as those for physical and chemical properties.

2. Identification information requirements when applying for inclusion to IECSC.

The identification information of chemical substances that the applicant should provide includes Chinese name, English name, CAS number, molecular formula, structural formula, etc. The identification information should be accurate and normative, obtained from authoritative institutions, or from published literature reports, authoritative databases, etc. Common names, common industry names, etc. are provided as aliases. The identification information of chemical substances should be consistent with the information related to chemical substances in the certification materials.

3. Annual activity report requirements

For a registered substance that needs to submit an annual activity report, an annual activity report should be submitted every year until the chemical substance is included in the Inventory of Existing Chemical Substances in China.

4. For a new chemical substance that has obtained a registration certificate MEP Order No. 7 and is re-registered under Order No. 12, should the previous certificate be cancelled?

The registration certificate for regular registration or simplified registration obtained under MEP Order No. 7 should be returned for a new registration certificate, and there is no need to cancel the registration certificate.

For more inquiries, please contact GPC via email compliance@gpcregulatory.cn

A re-assessment of use ahead of approval deadlines was carried out in late May in South Korea, where more than 20% of existing pre-registered biocidal substances under their domestic Consumer Chemical Products and Biocides Safety Act (K-BPR) were withdrawn.

According to the updated National Institute of Environmental Research (NIER) list published on May 24, the still-standing 452 biocidal substances, compared to that of 582 in the previous year, indicates there has been a reflection among companies to re-evaluate what substances to use ahead of deadlines for the completion of approvals, which led to a reduction in substances on the list.

Once removed from the list, the pre-registered substances have lost their pre-approved status, no longer owning the legality to be imported or manufactured for use as a biocide. Nevertheless, if the companies wish to extend the permit for activity until December 31, 2022, concerned parties can decide to submit a “Temporary manufacture/import plans in 2022” within 10 days from the notification date of a withdrawal/the rejection of an application.

Following the vast removal of the pre-registered substances, 116 product types have been removed from the listing regarding the allowed biocide product types covered under the aforementioned approval. However, despite the reduction in the approved number of chemicals, there is an additional product type for substance naphthalene for insecticides.

The deadlines for completion of approvals range from December 31, 2022, to December 31, 2029, depending on the product type where the substance is used. Companies are responsible for informing the downstream users of any changes in listing status for those substances in products or treated articles.

For the authority to process applications in time, NIER on March 31 also urged companies to submit dossiers by mid-April, where if the deadline was reckoned unlikely to be met, the substance would be withdrawn. Once again on May 11, NIER issued a notice in pursuit of completed dossiers that needed corrections or supplementary data, for that many applicants had failed to supply them.

The National Institute of Environmental Research (NIER) in South Korea updates ‘the results of hazard review of chemical substances’ under the Act on Registration and Evaluation of Chemicals (K-REACH).

The main updates are as follows:

• New substances

1) Updates on hazard information: "2017-297 (CAS 12078-25-0)", "2017-1034 (CAS 22029-36-3)", "2018-113 (CAS 34140-91-5)", "2018-654 (CAS 1431957-88-8)", "2021-55 (CAS 85508-44-7)", "2021-116 (CAS 94994-62-4)", "2021-144" and "2021-200 (CAS 27288-07-9)".

2) Addition of 48 substances and their hazard information: from "2022-124" to "2022-171".

• Existing substances

1) Updates on hazard information: "2020-012 (CAS 10043-35-3, CAS 11113-50-1)", "2020-043 (CAS 8001-58-9)", "2021-063 (CAS 85535-85-9)", "2021-133 (CAS 3236-71-3)", "2021-144 (CAS 13360-57-1)", "2021-158 (CAS 75-59-2)", "2021-159 (CAS 75-57-0)".

2) Addition of 88 substances and their hazard information: from "2022-224" to "2022-311".

The amendment came into effect immediately.

The National Institute of Environmental Research (NIER) in South Korea provides the list of banned substances for insecticide under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR). This is for identifying banned substances contained in insecticide products. The list includes 67 different biocidal substances.

The new clarification from the Australian Industrial Chemicals Introduction Scheme (AICIS) explains registration obligations under various circumstances to organizations that import or manufacture industrial chemicals or products. This includes universities, colleges, research institutes, charities, and non-profit organizations.

Being the regulatory body in Australia, AICIS on May 31 stipulated the mandatory registrations expected of relevant organizations, including organizations that import or manufacture small amount. It also does not matter if another university/organization already imports the same or similar chemicals from overseas, the process of registration will be the same, as it is for others.

The qualification process for registration applies to any organization involved in any of these activities:

• Buy chemicals from overseas for teaching or research,
• Manufacture industrial chemicals in a lab or classroom for teaching or research,
• Import or manufacture a low volume of chemicals with no threshold limit cast on the volume,
• Import or manufacture chemicals solely for non-profit research, or  
• Import or manufacture chemicals solely for a charitable purpose.  

The AICIS notice had clarified that organizations are not obliged to register blending or mixing ingredients purchased in Australia, goods and products not designed to intentionally release chemicals, or non-industrial chemicals. The AICIS has also provided information and guidance for registration regarding businesses and chemicals as well as those to-do-list after the organizations have completed the process.

After identifying 388 Food Contact Chemicals (FCCs) as “of concern” substances, Swiss researchers from the Food Packaging Forum (FPF) called for such substances to be phased out. These substances that are listed as being “intentionally added” to Food Contact Materials (FCMs) in the FPF’s FCC database (FCCdb) include:

• Carcinogenic, Mutagenic or Reprotoxic substances (CMRs),
• Endocrine Disrupting Chemicals (EDCs), and
• Persistent and Bioaccumulative substances (PBs). 

The database for the migrating and extractable FCCs, FCCmigex as labeled by FPF, has also listed some of the aforementioned substances, where 97 of such chemicals were found evidently migrating from FCMs. Part-funded by environmental NGO Zero Waste Europe, the research league including colleagues at ETH Zurich and the Swiss Federal Institute of Aquatic Science and Technology spotted the need to investigate a wider range of FCCs in extraction and migration experiments; the ultimate calling is that no untested substances and no hazardous chemicals shall be present in FCMs.

The Federal Office of Public Health, Switzerland, on 28 June 2022 published a draft amendment of Annexes 2, 3, 4, and 7 of the Ordinance on Protection against Dangerous Substances and Preparations (Chemicals Ordinance).

Annex 2 is the technical regulations for the classification, labelling and packaging of substances. It will be updated and adapted to technical progress in the EU from November 23, 2023. The draft revises the list of harmonized classifications and updates it to include 39 substances, amends 17 existing entries and one existing entry was split into two. Also, the newest developments in test methods for substances and preparations (OECD) are adopted in this draft revision.

For Annex 3, four substances are added to the candidate list of substances of very high concern (SVHC). The requirements in Annex 4 (technical dossier for notifications) are updated based on the specifications for registrations in the EU. And three entries are eliminated from Annex 7, the list of new substances for which notification is not required.

With these revisions, the agency aims to protect human health and the environment and reduce trade barriers to enhance trade in Switzerland. The last day for comments is July 15, 2022, and the proposed date of adoption is July 29, 2022. The changes are expected to come into force on September 1, 2022.