Other Regulatory News

According to the Danish Environmental Protection Agency and Danish Consumer Council THINK Chemicals, specific children’s toys have been discovered to contain some chemicals that are problematic....

According to the Danish Environmental Protection Agency and Danish Consumer Council THINK Chemicals, specific children’s toys have been discovered to contain some chemicals that are problematic.

The Danish Consumer Council THINK Chemicals discovered that fidget toys, also known as pop-it or anti-stress toys have various chemicals that are harmful. Therefore, advises parents to keep such toys away from their kids. The Danish EPA also warns against the use of pea-pods bought from Wish.

Fidget toys refer to the toys that can be squeezed, pressed, pulled, or moved to keep a child’s hands active.

After testing 21 different types of fidget toys, the following were discovered:

• Pea pod keychains from wish.com contain phthalate DIBP in high values, above the legal limit. Additionally, DIBP was banned in EU from usage in toys and other products due to its endocrine disrupting nature. The Danish EPA recommends that every pop-it pea pod be disposed as the Swedish Chemicals Agency sends a request to wish.com for a marketing halt of these products. This request was made in accordance with the agreement between several e-commerce platforms and the EU Commission (Product Safety Pledge) to be able to stop marketing products that are not documented in accordance with EU legislation.
• Four fidgets contain PAH naphthalene, which is possibly carcinogenic. The substance’s amount is also above the German recommendation for toys that encounter children’s skin in all the four toys. The only carcinogenic PAH not prohibited in toys is naphthalene. These four fidgets are: Edamame keychain from Lightinthebox, Orange chicken from Chao Chao, Cute peanut-shaped popper from Bent, and Bendable smiley man from ABC-leg.
• Pop-it toys contain problematic siloxanes; these are toys children play with by pushing small bubbles up and down on a silicon plate. The three pop-it toys that were tested all contain siloxanes D4, D5, and D6. These siloxanes are listed on the EU’s official list of substances of very high concern (SVHC) for dangerous to the environment and health. However, the existence of siloxanes in pop-it toys are legal and the agency is uncertain about the migration of these chemicals from the silicone to the children when they play with them.

Considering the dangers these toys are likely to pose to children, it is highly important that agencies and chemical regulation governing bodies appropriately and adequately research and regulate the chemical substances used in making toys.

Last Update: 2021-11-30

In September, Chile reaffirmed commitments with the Latin American Regulatory Cooperation Forum (LARCF), an association promoting dialogue and information exchange, training initiatives, and regulatory cooperation through national chemical associations. At a recent meeting, the Chilean authorities demonstrated how the forthcoming notification platform would perform.  

Authorities intend to gradually submit the system to new usability tests; therefore, other testing and showcase sessions will take place until December 2022. Currently, the system can record new substance notifications, including:  

• If the substance is produced or imported  
• Substance information (official and common names, CAS number)  
• Substance hazard class and hazard category  
• Type of use, sector, and product category  
• Imported/manufactured quantity  
• Substance SDS uploads  

The substance notification was created under the new chemical management regulation (Decree 57), published in February 2021. The first notification window is scheduled between February 2024 and August 30, 2024, indicating that non-industrial substances notified after the initial notification period will be handled as “new substances”. Accordingly, an official national chemical inventory will be published by December 31, 2024.  

In Chile, manufacturers and importers shall submit updated information (e.g., tonnage bands) every two years through the notification portal as part of the notification system. In addition, certain substances are required to undergo risk assessment, although the substance list and assessment criteria have until June 30, 2022, to be published. 

 On August 23, 2021, Chile published the official list for the classification of chemical substances through Resolution 777. The list, commonly referred to as “Official List of Substances Classification”, is based on the GHS 7th version.  

Manufacturers exporting chemicals to Chile are recommended to follow up the latest regulatory obligations and start preparing. 

Last update: 2021-11-05

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

On July 24, Peru’s Ministry of the Environment (MINAM) published Decree 18/2021. By this Decree, Peru creates the Pollutant Release and Transfer Register (RETC by its acronym in Spanish).

The new database constitutes a new informational tool of potentially harmful chemical products and substances. The purpose is to facilitate public access to information on releases and transfers of pollutants while contributing to decision-making processes on environmental management.

Since the new regulation is broad in scope, different economical activities are required to comply. It includes, agriculture, mining, manufacture, suppliers, providers, transport, and storage facilities. A complete list of those who need to comply is displayed in Annex 1.

The report must include three parameters: chemical substances, their physicochemical characteristics, and total hazardous waste produced. Annex 2 give further details on such elements.

Altogether, the declaration content must have:

• Company information, operations, and processes
• Water and energy consumption
• Emissions amount (air, water, and soil)
• Sewage and waste amounts
• Company’s environmental practices and certificates

Declarants have until March 31st of each year to report. The declaration must be made once a year through the RETC digital platform.

The Decree foresees a 3-year adaptation period becoming mandatory in July 2024. Companies can still report voluntarily until then. The Peruvian authorities published a guideline to assist in reporting.

The initiative is linked towards enhanced chemical management in Peru. The Ministerial Resolution 439/2020, which proposes the National Regulation and Control of Dangerous Substances and the GHS adoption underwent public comments in September 2020. This may indicate a new version coming to light in 2021.

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 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/