Other Regulatory News

Circular Economy has been on the rise, and debates about its adoption, key elements, benchmarks, and range of application are prevailing than ever before. In November 2021, the Organisation&...

Circular Economy has been on the rise, and debates about its adoption, key elements, benchmarks, and range of application are prevailing than ever before. In November 2021, the Organisation for Economic Co-operation and Development (OECD) published a paper focusing on Circular Economy Labels and Information Schemes (CELIS). 

The document provides an overview of labels, certifications, and standards that address circular economy aspects, assesses the drivers and barriers preventing the leverage of such communication elements, and identifies circular economy components that can be best applied to the disclosure landscape. 

In respect to these objectives, the paper points that: 

• Information asymmetry or scarcity negatively impact resource efficiency and circularity, leading to inefficient decision-making along the supply and value chains; 

• Although there was an increase in environmental labeling and information schemes, studies have prioritized consumer-oriented labels while setting information disclosure business-to-business aside. Confidential business information and intellectual property rights are pointed as barriers for the information system uptake; 
• Governments are key to enhancing and improving circular economy communication elements, for example, facilitating methodological advancements to support criteria integration (product lifespan, durability, reparability, etc.), developing an information system through regulatory information disclosure requirements, and supporting the harmonization of information systems and metrics; 

Ultimately, CELIS can play an important role in enhancing and improving circular economy activities. The paper is available in the OECD library.  

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.

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

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

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

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

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

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

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

p.13-14 phased out items:

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

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

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.