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GHS Report

GPC Newsletter Mar-2022



Regulatory News

The Health Canada’s revised in-commerce list (R-ICL) of chemicals used in food, drugs, and cosmetics no longer includes 602 substances that are not commercially active. These substances are therefore not subject to notification under the Food and drug Act (F&DA).

The R-ICL is a list of substances used in products introduced into commerce between 1 January 1987 and 13 September 2001. Substances listed under the New Substance Notification Regulation (NSNR) are not subject to notification requirements for F&DA-related uses.

As proposed in October, the government aimed to remove 544 substances produced or imported in quantities less than 100 kilograms yearly. It also aimed to delist 125 pharmaceutical ingredients that were discontinued or never marketed.

In an announcement on 18 February, the government said that it was removing all 125 pharmaceutical ingredients and all 477 substances below the 100kg annual threshold.

67 chemicals were not removed at this time, according to Health Canada, "because they were identified as potentially having commercial activity in Canada." However, removed substances can re-enter the Canadian market through the NSNR, which come under the Canadian Environmental Protection Act, 1999 (CEPA).

The Canadian government has posted draft screening assessments for a batch of 34 chemical compoundsinclusive of lithium- and barium-containing substances. The government recommends that they pose a "low chance of damage to the environment".


The draft assessments under the Canadian Environment Safety Act (CEPA) endorse that the 34 substances do now not meet health or environmental hazard criteria essential for further regulatory movement. Consistent with the outcomes of a CEPA survey, most of the substances do not have direct consumer usesHoweversome can be used to make food packaging materials while others are present in products available to customers along with cosmetics, sealants, and disinfectants.

In the draft screening assessment, ecological risks were characterised using the Ecological Risk Classification for Inorganic Substances (ERC-I). Based on the ERC-I analysis, the 34 substances in the assessment are considered "unlikely to cause ecological harm". As part of the screening, human biomonitoring data or "rapid screening" was analyzed to evaluate the potential for direct exposure from products as well as indirect exposure through the environment.

 

The government proposes that the substances do not meet any of the criteria in CEPA's section 64, which defines a substance as toxic if it enters the environment in a way that may cause harm based on the evidence presented in the draft screening assessment.

 

The 34 substances include lanthanum oxide, bismuth-containing substances, lithium, lithium chloride and lithium fluoride, as well as various other lithium salts.

The Pest Management Regulatory Agency (PMRA), on 7 March 2022, proposes a maximum residue limit for Pyraziflumid (PMRL2022-02).  

The proposed limit includes:

MRL (ppm)1

Raw Agricultural Commodity (RAC) and/or Processed Commodity

6.0

Bushberries (crop subgroup 13-07B)

4.0

Caneberries (crop subgroup 13-07A)

2.0

Stone fruits (crop group 12-09), raisins

1.5

Small fruits vine climbing, except fuzzy kiwifruit (crop subgroup 13-07F)

0.4

Pome fruits (crop group 11-09)

0.03

Tree nuts (crop group 14-11)

 

You can comment on this consultation before May 15, 2022. And the rule is meant to come into force between four to five months of posting the proposed MRL. 

On March 9, 2022, US EPA published the final rule for regulating Phenol, Isopropylated Phosphate (3:1). The regulation for this substance is promulgated under the Toxic Substances Control Act (TSCA).


The final rule concerns the extension of the substance’s compliance date for commercial processing and distribution. The new compliance date for the substance’s prohibition is October 31, 2024.

The final rule is effective from March 8, 2022, and will be promulgated by March 22, 2022. The full document is available on our website here

On 9 March 2022, the Environmental Protection Agency (EPA) announces the decision to extend the compliance date for prohibiting the processing and distribution of Phenol, Isopropylated Phosphate (3:1) [PIP (3:1)] in the US.

 

This applies to PIP (3:1)-containing articles and the PIP (3:1) used in making those articles. The new extension date for compliance is October 31, 2024. This means that affected businesses, manufacturers, and importers have from now till October 2024 to stop using PIP (3.1) and also to comply with the recordkeeping requirements for manufacturers, processors, and distributors.


This is the final rule which will be formally effective from March 22, 2022. The rule affects you if you are a manufacturer, importer, processor, distributor, or user of PIP (3:1) or PIP (3:1)-containing articles. 

On March 22, 2022, the European Commission held its second stakeholders’ workshop on “Safe and Sustainable by design (SSbD) criteria for chemicals and materials”. The development of criteria to assess the safety and sustainability of chemical substances is one of the main actions under the EU’s Chemicals Strategy for Sustainability.  While the relation of these criteria to specific regulatory initiatives is still unclear, they will be of immediate relevance for non-legislative initiatives and set an official definition that may serve as a basis for compliance obligations at a later stage.

At the workshop, European Commission representatives and stakeholders from civil society organisations and the chemicals industry discussed the overall framework for the assessment of the safety and sustainability of chemicals. The Commission expects to hold a follow-up webinar in April, where it will respond to the feedback provided by stakeholders.

The current proposal by the European Commission’s Joint Research Centre consists of a 4-step process. Three of the steps would relate to the safety of a chemical. Specifically, they would address its properties, its processing, and its uses. The fourth and final step would assess the environmental performance of a chemical from a life-cycle perspective.

The workshop is the second one of a series of three. A first workshop, held on 19 March 2022, presented the framework and timeline for the development of the SSbD criteria. A third and final workshop will be held in the third quarter of 2022, where specific case studies will be discussed before publication by the Commission of the criteria. The case studies currently under consideration are non-phthalate plasticisers, surfactants, and halogen-free flame retardants.

 

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. 

Download here

On March 11, 2022, the commission announces its decision of a biocidal product in line with Regulation (EU) No 528/2012 of the European Parliament and of the Council. A product that contains capsicum oleoresin expeller pressed to be used as a repellent against cats and dogs is classified a biocidal product. Therefore, it falls under product-type 19 which is defined by the regulation as products used to control harmful organisms like fleas, rodents, etc., by repelling either directly on the skin or indirectly in the environment.


Biocidal products are necessary, however, they pose risks to humans, animals, and the environment. The commission is committed to ensuring the movement of biocidal products in the European Union while ensuring that humans, animals, and the environment are highly protected against its risks.


Therefore, this decision notifies an addition to the list of biocidal products and the proposed date of adoption is June 2022 and comments are open till May 9, 2022.

On March 4, 2022, Sweden proposes to ECHA to identify N-(hydroxymethyl)acrylamide (with CAS No 924-42-5) in the list of Substances of Very High Concern (SVHC).

SVHC list consists of substances considered to have serious effects on human health and the environment, which are usually irreversible. To use any substance in this list, authorization has to be requestedThe identity of the substance and the PBT or vPvB properties and properties of equal concern are needed for commenting on this proposal.

The last day to comment is April 19, 2022. You can comment here. 

On the 7th of March 2022, the EU notifies the decision to not approve N-(3-aminopropyl)-N-dodecylpropane1,3-diamine as an existing active substance for use in biocidal products. This decision was made due to the human health risks posed by the substance. The EU focuses on harmonizing the EU market for biocidal products while protecting human health and the environment.

During the assessment of the substance in 2020, ECHA identified an unacceptable risk both for primary and secondary exposure, relating to industrial users and the scenario of infants and toddlers playing on the playground, respectively. However, there is no unacceptable risk for the environment if the appropriate measures are taken. Combining the two assessments, the conclusion is that there is no safe use or mitigation measures that can be adopted for avoiding the substance’s health risks.


The final date to comment on this proposal is the 6th of May 2022. 

European Commission publishes 12 delegated acts to end the exemptions for the use of mercury in lamps. These lamps include general-purpose compact (CFL) and linear fluorescent (LFL) lamps. Considering the wide availability of mercury-free alternatives, this announcement will enter into force on March 16, 20 days from when it was published. The EU Member States have six months to modify their national legislation to include these delegated acts.

Before now and according to the EU rules (RoHS Directive) that restricts the use of hazardous substances in electronic equipment, electronics with mercury can only be placed on the market when certain exemptions are given by the Commission.

However, according to this new announcement, the Commission cancels all exemptions regarding the use of mercury. Mercury-free alternatives are widely available for industries and manufacturers to use. This is in response to the proposal submitted to the European Parliament and Council in December 2021.

On the 23rd of February 2022, the REACH Annex XV restriction dossier was published addressing PFASs’ risks in firefighting foams to human health and the environment. The European Chemicals Agency (ECHA) proposes an EU-wide restriction on all per- and polyfluoroalkyl substances (PFASs) in firefighting foams.

The proposal by ECHA is aimed at preventing further contamination of the soil and its health risks to people and the environment. It is known that PFASs have caused environmental contamination to the soil and drinking water in the EU.

If adopted, there will be a transition period for industries to replace PFASs in the firefighting foams. Industries will also have to properly dispose expired and waste foams while transitioning away from using these PFASs. The consultation period for this proposal starts from the 23rd of March 2022 for six months, during which anyone can give comments.

Based on the proposal, the transition period will include:

  • three years for civilian ships
  • five years for portable fire extinguishers
  • five years for any other use
  • 8 months for training and testing
  • 10 years for fire service establishments covered by the Seveso Directive, and
  • 18 months for municipal fire services (except if they are also in charge of establishing industrial fires, which is covered by the Seveso Directive)

The Indian Government proposes a new Draft National Policy for Medical Devices, 2022, to reduce India's reliance on high-end medical device imports. The government intends to adopt public-private partnerships to reduce healthcare costs, increase efficiency, and improve the quality of medical devices manufactured in the country.

 

Among the key proposals are:

 

·       The use of tax breaks and refunds to encourage the export of medical devices and related technology projects.

·       Increasing government spending on "high-risk" medical device projects

·       A single-window clearance system to be used for the licencing of medical devices.

·       Pricing environment with no price control on newly developed sector innovation

·       A dedicated fund to be established for encouraging collaborative research among existing industry players, reputable academic institutions, and start-ups.

·       Incorporate a framework for consistent pricing regulation to make high-quality, cost-effective medical devices available to all citizens at reasonable prices.

·       The National Pharmaceutical Pricing Authority (NPPA) will be strengthened with adequate manpower and appropriate expertise to provide effective price regulation while balancing the needs of patients and industries.

India started consultation on a draft international standard (IS) for sodium hypochlorite, also known as bleach. The item is described as an inorganic chemical widely used as bleach liquor. It is generally sold in aqueous solutions, according to the draft published by the Bureau of Indian Standards (BIS) on February 21.

 

Bleach is considered a significant safety risk by the BIS due to the substance’s corrosive characteristics, widespread availability, and reaction products. 

These follow the provisions of five other standards:

1.     Glossary of terms relating to chemical and radiation hazards, as well as hazardous chemicals (IS 4155: 1966);

2.     Guide for selection of industrial safety equipment for body protection (IS 8519: 1977);

3.     Guide for selection of industrial safety equipment for eye, face, and ear protection (IS 8520: 1977);

4.     Guide for selection of industrial safety equipment for protection of arms and hands (IS 8807: 1978);

5.     Guide for selection of industrial safety equipment for protection of arms and hands (IS 88 (IS 10667: 1983).

In addition, the proposal suggests that substance containers be marked or labeled to identify:

·       The manufacturer's or importer's name and address.

·       The contents of the container; and the physical, chemical, and toxicological data as specified in the relevant Schedule of the Hazardous Chemicals Manufacture, Storage, and Import Rules 1989.

Furthermore, if sodium hypochlorite poses, or is likely to pose, health dangers in the workplace, the draught mandates the use of personal protective equipment (PPE). Employers would be responsible for selecting and providing suitable personal protective equipment (PPE) to employees, ensuring that it is used properly, and training them on all elements of the PPE.

The consultation period will end on April 22, 2022.

The Department of Chemicals & Petrochemicals on March 11, 2022, published its decision to extend the Quality Control Order implementation date for six chemical products. The new implementation date is September 13, 2022. The concerned chemical products are:

1. Acetone (Quality Control) Order, 2020

2. Gamma Picoline (Quality Control) Order, 2020

3. Beta Picoline (Quality Control) Order, 2020

4. Potassium Carbonate (Quality Control) Order, 2020

5. Pyridine (Quality Control) Order, 2020

6. Sodium Tripolyphosphate (Quality Control) Order, 2020


You can view the official gazette here. 

On March 10, 2022, the Department of Chemicals & Petrochemicals publishes its decision to extend the Quality Control Order implementation date for five chemical products. The new date is September 12, 2022. The concerned chemical products are Ethylene Dichloride, Vinyl Chloride Monomer, Acrylonitrile Butadiene Styrene, and Polycarbonate. 


You can view the official gazette here

The Bureau of Indian Standards launch a consultation on a draught amended standard for terephthalic acid, which includes new standards, sampling techniques, and testing on February 23, 2022.


The first edition of the standard was released in 2001. In this (first) iteration, test procedures for determining colour, ash, and acid value have been updated to reflect the most recent technological advances. The HPLC method for determining the amount of 4-carboxybenzaldehyde (4-CBA) and p-toluic acid (p-TA) has also been changed. The test technique for determining p-toluic acid, 4-carboxybenzaldehyde, and benzoic acid in purified terephthalic acid using normal voltage mode capillary electrophoresis, as well as the test method for determining titanium in Annex E, have been incorporated. IS 15030: 2001 Amendment No. 1 has been incorporated into this revision.


Terephthalic acid is a popular constituent in paints, synthetic fibres, and resins, as well as a step in the production of polyethylene terephthalate (PET) for liquid packing and polyester films.

Because of the substance's flammable and explosive properties, the BIS has proposed modifying the standard. This includes the following requirements: 

IS No.

Title

265: 2021

Hydrochloric acid — Specification (fifth revision)

266: 1993

Sulphuric acid — Specification (third revision)

460 (Part 1): 2020

Test Sieves — Specification Part 1 Wire Cloth Test Sieves (fourth revision)

915: 2012

Laboratory glassware — One - Mark volumetric flasks (third revision)

1070: 1992

Specification for water for general laboratory use (third revision)

2362: 1993

Determination of water by Karl Fisher method — Test Method (second revision)

4161: 1967

Specification for Nessler cylinder

 

The technique for obtaining representative samples of the material and the compliance criteria shall be as specified in IS 5299, section 4. The BIS is soliciting comments through March 19 on the modifications to Indian Standard (IS) 15030:2001.


Kindly refer https://www.gpcgateway.com/uploads/media/Nb5PCtiqypot4lwCTxsyqdsWm.pdf for more information. 

On 16 February 2022, the Ministry of Environment, Forest and Climate Change published the Plastic Waste Management (Amendment) Rules, 2022, amending the Plastic Waste Management Rules, 2016. The Rules brought in Extended Producer Responsibility (EPR) to ensure a collective system of plastic wastes by the producer and brand owners.

The amended guideline provides the framework for further implementation of EPR and the prohibition of identified single-use plastic items with effect from July 01, 2022. Generators of plastic waste have to minimize plastic waste generation, not litter the environment with plastic waste and store them according to the rules.

The Rules affect importers, brand owners and plastic waste processors as the entities that fall under the category of Extended Producer Responsibility. They have to register in the centralized portal developed by Central Pollution Control Board (CPCB). The new rules classify plastics into four categories and mandate recycling and reusing a certain percentage of plastic produced and used by manufacturers, importers, and brand owners. From 2018 to 2021, 310 companies have been approved as brand owners and four companies have been approved as producers.

Brand Owners (BO) include online platforms/marketplaces, supermarkets/retail chains other than those, micro and small enterprises as per the criteria of Ministry of Micro, Small and Medium Enterprises, Government of India.


CPCB is also preparing an online portal and this will be the single point for the registration as well as filing of annual reports by producers, importers, brand-owners, and plastic waste processors of plastic packaging waste. The portal is expected to be ready by March 31, 2022.

The amended Rules also lay out a roadmap for upcoming activities (see below Table). 

Category

Classification

2024-25

2025-26

2026-27

2027- 28 and onwards

Category I

Rigid plastic packaging

50

60

70

80

Category II

Flexible plastic packaging of single layer or multilayer (more than one layer with different types of plastic), plastic sheets and covers made of plastic sheet, carry bags, plastic sachet, or pouches.

30

40

50

60

Category III

Multi-layered plastic packaging (at least one layer of plastic and at least one layer of material other than plastic)

30

40

50

60

Category IV

Plastic sheet or like used for packaging as well as carry bags made of compostable plastics fall.

50

60

70

80


For example, Category I needs to comply with 50% recycling and reusing of plastics by 2025 and Category III needs to comply with 30% recycling and reusing by 2025.

According to the Standard Operating Procedure (SOP) for Producers, Importers, and Brand Owners (PIBOs) that was amended and published in March 2021, registrants need to provide documents such as proof of selling in more than two states, valid consents under Air and Water Act (if the unit has ap production facility), documents related to Action Plan and others.

PIBOs are expected to submit progress reports half-yearly, addressing their management of plastic waste for each State in their Extended Producers Responsibility action plan. The submission should be done within 15 days from completing the preceding half-year team. The report should indicate the quantity as well as the type of plastic waste, the evidence of state-wise collection of waste according to EPR target and the details of your plastic waste collection, management, and processing.

PIBOs must provide the details of recycling certificates only from registered recyclers, as well as the quantity sent for end-of-life disposal, by June 30 of the next fiscal year, while making yearly returns on the online portal.

To know your compliance requirements, contact compliance@gpcregulatory.com 

Click here to view the Official Gazette 

At the UN Environment Assembly that happened from 28th February to 2nd March, along with Japan, India has placed another proposal on the table which states an alternative resolution on single use plastics. It focuses on a voluntary framework rather than a mandate for the creation of a legally binding global agreement.

The resolution, introduced on October 20 by Rwanda and Peru and co-sponsored by 53 countries including Norway, Chile, Pakistan, and the EU, is considered the most ambitious and calls for a full life cycle approach to plastics, addressing plastic production as well as harmful additives and waste management. It proposes an open mandate for a negotiating committee, which means that as discussions progress, negotiators could work on a wide range of issues related to plastic pollution, such as "product design and use, including compounds, additives, and harmful substances, as well as intentionally added microplastics."

A second resolution, submitted by Japan on December 6 and supported by Antigua and Barbuda, Cambodia, Palau, and Sri Lanka, is more limited in scope. The resolution focuses on plastic waste management (rather than production) and proposes a closed mandate, which means that negotiators could only address this aspect of plastic pollution when negotiating an agreement. Meanwhile, India jumped into the fray at the last minute with an alternative resolution on single-use plastics, which was published on January 31. Unlike the other proposals, India's document emphasises a voluntary framework rather than a mandate to create a legally binding global agreement. Several UN member states have requested that the two original proposals be combined prior to the main meeting. In January, more than 70 consumer brands, including Coca-Cola, PepsiCo, Unilever, and Ikea, issued a joint statement outlining plans to reduce plastic production and use.

On  February 15, 2022, the National Medical Products Administration of China (NMPA) published final measures for cosmetic companies to establish systems for monitoring adverse reactions of cosmetics. It is expected to come into force on October 1, 2022. This measure will apply to all companies who register/notify their cosmetic or cosmetic ingredients under Cosmetics Supervision and Administration Regulation (CSAR).


This measure consists of seven chapters that extensively lay down rules relating to the responsibilities and obligations for notifiers, cosmetics’ adverse reaction report requirements, adverse reaction analysis and evaluation, investigation on adverse reaction, and administration supervision methods.


According to the measure, adverse reaction means a normal and proper use of cosmetics resulting in pathology change in skin and other related health issues. For better monitoring of the adverse reaction, companies are required to establish post-registration adverse reaction monitoring systems. Such systems will be used to collect information on adverse reactions to cosmetics sold via various channels including distributors, shops, and hospitals. Domestic companies are required to report all this collected information to NMPA, while overseas companies comply with this via their Chinese responsible person such as their Only Representative  (OR) and importer. Though the information will be submitted to NMPA, all the collected information must be kept for at least three years.

Further, this regulation categorizes the reactions into three types according to their severity level:

  1.  Normal adverse reactions, which means minor ailments such as itchiness and rashes.
  2. Severe adverse reactions. It refers to large-scale or deep damage to the skin and organs, including mucous membranes and systemic damage to other organs.
  3. Extremely severe adverse reactions. It means those that might impact a lot of people or have a large social impact.


Based on different categories, the notification timeline is different. Normal adverse reactions must be reported to NMPA within 30 days when the adverse reaction is found, while reporting time for severe and extremely severe situations are shortened to 14 days and 3 days respectively.

For more inquiries regarding Chinese cosmetic regulation and compliance issues, please contact us via compliance@gpcregulatory.cn or send a message to our WeChat account of 46 0708381983 (GPC China). 

The Ministry of Environment (MoE) in South Korea pre-announced the legislation to update K-REACH. This is aimed at simplifying K-REACH data submission for new substances under 1 TPA (Tonnes per Annum) and easing exemption requirement on new substance reports for Research & Development purposes.

Environmental hazard data (acute toxicity to fish, acute toxicity to daphnia, biodegradability) can be omitted when registering new substances that are manufactured or imported under 1 TPA and when any of the following applies:

·       With water solubility less than 1/

·       For intermediates use or process regulators use

 

Also, if an overseas manufacturer/producer does not provide the name and identification number of a substance to be imported due to trade secrets, Material Safety Data Sheet (MSDS) can be submitted instead.

In February 2022, the Ministry of Food and Drug Safety (MFDS) in South Korea proposed amendments to the ‘Regulation on Safety Standards, etc. of Cosmetics’. This is the cosmetics policy enacted in 2015 to guide the manufacture and import of cosmetics and their safety control, it provides a framework for determining the raw materials that can not be used in cosmetics.

The Ministry proposes that persistent pollutants, some components of perfluorinated compounds and 1, 2, 4-trihydroxybenzene should be added to the list of prohibited ingredients while benzalkonium chloride should be prohibited from use as a preservative in spray-type products. It also proposes the maximum limit concentration of ingredients used as hair dye.

Furthermore, some prohibited ingredients are to be established as new exceptions. There are proposed management standards for CBD and THC and radioactive materials and fluorescent brightener 367 have new permissible limits.

The final date to comment on this notification is April 28, 2022. 

Australia Competition and Consumer Commission (ACCC) reviews the voluntary Australian standard and proposes a new compulsory safety standard on February 25, 2022. This new rule mandates suppliers’ compliance to the newest standard called Australia/New Zealand Standard on safety aspects related to mechanical and physical properties.

Furthermore, ACCC proposes that suppliers should comply with any of these overseas voluntary standards:

1.       International Standard on safety aspects related to mechanical and physical properties

2.       European Standard on mechanical and physical properties

3.       American Standard on standard consumer safety specification for toy safety

The proposed change is not to amend any rule in the voluntary standard but to ensure compliance with the existing rules compulsory for suppliers. The final comment date for this proposal is April 29, 2022, while the proposed date of entry will be a transitional period of 18 months for suppliers to adopt the new requirements.

On  7 March 2022, Australia notified the changes to its laws regarding Mercury, in a bid to comply with the Minamata Convention obligations. Due to the amendment, Australia now prohibits the import and export of elemental mercury, also known as metallic mercury. The new rule to prohibit products that contain mercury became effective on March 7, 2022.  The prohibited products are: 

  • Batteries, except for button zinc silver oxide batteries with a mercury content <2% and button zinc air batteries with a mercury content <2%
  • Switches and relays, except very high accuracy capacitance and loss measurement bridges and high frequency radio frequency switches and relays in monitoring and control instruments with a maximum mercury content of 20mg per bridge, switch or relay
  • Compact fluorescent lamps (CFLs) for general lighting purposes that are ≤30 watts with a mercury content exceeding 5mg per lamp burner
  • Linear fluorescent lamps (LFLs) for general lighting purposes:
    1. Triband phosphor <60 watts with a mercury content exceeding 5mg per lamp
    2. Halophosphate phosphor ≤40 watts with a mercury content exceeding 10mg per lamp
  • High pressure mercury vapour lamps (HPMV) for general lighting purposes
  • Mercury in cold cathode fluorescent lamps and external electrode fluorescent lamps (CCFL and EEFL) for electronic displays:
    1. Short length (≤500mm) with mercury content exceeding 3.5mg per lamp
    2. Medium length (>500mm and ≤1500mm) with mercury content exceeding 5mg per lamp
    3. Long length (>1500mm) with mercury content exceeding 13mg per lamp
  • Cosmetics (with mercury content above 1ppm), including skin lightening soaps and creams, and not including eye area cosmetics where mercury is used as a preservative and no effective and safe substitute preservatives are available
  • Pesticides, biocides and topical antiseptics
  • The following non-electronic measuring devices except non-electronic measuring devices installed in large-scale equipment or those used for high precision measurement, where no suitable mercury-free alternative is available:
    1. Barometers
    2. Hygrometers
    3. Manometers
    4. Thermometers
    5. Sphygmomanometers


The new Resolution 589/2021 entered into force in Brazil in January, 2022,. The National Health Surveillance Agency (ANVISA) Resolution revises three pieces of national legislation on food contact materials and articles:

·       Resolution 105/1999: General provisions for plastics in food contact

·       Resolution 56/2012: Positive list for plastics in food contact

·       Resolution 88/2016: Cellulosic materials, packaging and equipment intended to come into contact with food


The modifications of Resolution 589/2021 complements and transpose MERCOSUR Resolutions 19/2021, 20/2021 and 21/2021 into national law on food contact materials and articles. Main modification includes:

·       In Resolution 105/1999: Amends the requirements for overall migration and new requirements for coatings that are applied on containers

·       In Resolution 56/2012: Specific migration of primary aromatic amines, adds several substances to Part I and revisions on Part IV of the annex.

·       In Resolution 88/2016: adds three entries and amends another one to the positive list, all with specifications


Businesses dealing with food contact material articles have 12 months to comply with the requirements established in the standard. Therefore, the deadline is to be on January 3, 2023.

In February 2022, the Brazilian Health Regulatory Agency (ANVISA) submitted a proposal for including substances/organisms as active ingredients into authorized monographs authorized in Brazil. The proposal IS open for public consultation for 60 days counting from its publication.

Such active ingredients may be used in agrochemicals, sanitizers, disinfectants, and wood preservatives. Along with the list, the following substances are being considered, respecting the following contribution deadlines:

Monograph Index

Substance/Organism

CAS #

Deadline

C84

Catolaccus grandis

-

10/04/2022

C85

Cinnamomum verum

-

I31

Isaria javanica

-

P64

Pseudomonas oryzihabitans

-

17/04/2022

T78

Trichoderma viride

-

01/05/2022

D57

1,4-Dimethylnaphthalene

571-58-4

01/05/2022


 

The intention to include the substances/organisms in the authorized list has been communicated to the World Trade Organization.

On February 9, 2022, the National Health Surveillance Agency (ANVISA) published a resolution addressing ultraviolet (UV) filters allowed to be present in cosmetics. In addition, Resolution 600 formally adopts MERCOSUR's resolution 44/2015 amended by MERCOSUR 14/2021.

In summary, Resolution 600  allows 36 UV filters in cosmetics, establishes a maximum concentration limit for each substance, and enacts other limitations for specific substances. An important detail is that the list only includes those substances added into sunscreen products focused on avoiding damage caused by UV rays. Among the substances are:

Substance

Maximum authorized concentration

Triethanolamine Salicylate

12%

4-Aminobenzoic Acid

15%

Titanium Dioxide

25%

Zinc Oxide

25%

Drometrizole Trisiloxane

15%

 

Failure to comply with the provisions constitutes a sanitary infraction. Businesses should check the complete list and how the resolution might impact their activities.

On February 24, 2022, the Latin America and the Caribbean Circular Economy Coalition launched a document envisioning a stronger Circular Economy vision for the region. It intends to inspire governments, stakeholders, and initiatives towards a common goal of sustainable economic development based on circularity.

The Circular Economy in Latin America and the Caribbean: a shared vision considers the regional characteristics when proposing transitional activities from linear economy to a circular one. The initiative is spurred on by the growing global drive to pursue long-term economic prosperity.

Just after a year of its launch (February 2021), the Latin America and the Caribbean Circular Economy Coalition has brought together dozens of government officials, representatives from relevant international institutions, businesses, and academia to accelerate the transition to a circular economy and imagine the future of the region based on a circular economy functioning at scale.

The document is believed to facilitate dialogue, engagement, and exchange, resulting in

·       alignment of policies from developing common standards to developing international policies such as trade and in turn enhance development opportunities

·       interoperability of policy and business schemes, for example by aligning on collection and sorting schemes to sharing a classification or taxonomy scheme.

·       help nurture an inclusive and just transition within countries and regions, for example through the exchange of best practice and understanding of investment needs.

The document is available in English, Spanish, and Portuguese.

Chile’s Environmental Ministry (MMA) promulgated on February 28, 2022, a Decree establishing collection and recycling goals for batteries and Electrical and Electronic Equipment (EEE). Furthermore, Decree 207/2022 imposes obligations associated with priority products, batteries and electrical and electronic devices in order to prevent the generation of such waste and promote its reuse or recovery.


All batteries and EEE present in the Chilean market up to 1500 volts direct current or 1000 volts alternating current falls under scope. It is further established batteries and EEE categories and subcategories, which are:

·       Large Devices: EEE with an external dimension greater than 50 centimeters

o   Temperature Exchange Devices.

o   Other Large Devices.

o   Photovoltaic panels.

·       Small Devices: EEE not contained in the Large Devices category

·       Large Batteries: Batteries with a weight greater than 5 kilograms.

·       Small Batteries: Batteries not contained in the Large Batteries category.


Decree 207/2022 also provides limits of hazardous substances in batteries. Chile banned Large Batteries with mercury concentrations greater than 0.1% by weight and Small Batteries with cadmium concentrations greater than 0.01% by weight. Emergency equipment, alarms, and medical devices are exempt from this rule.

The collection goals shall reach a minimum threshold, continuously increasing each year:

Year

1st

2nd

3rd

4th

5th

6th

7th

8th

9th

From 10th on

Batteries and EEE

3%

5%

8%

12%

16%

20%

24%

30%

37%

45%

Temperature Exchange Devices

-

-

6%

9%

13%

17%

21%

25%

30%

30%



Management systems may be individual or collective. Individual management system and collective system composed with a maximum of 20 independent producers must reach indicated goal based on batteries and EEE amounts placed into the market. Larger management systems may meet their targets with any batteries and EEE waste, not necessarily those produced or imported by them.

Interested parties may submit comments within 30 business days, counting from the publication date (March 10). Observations must be sent via the Citizen Consultations Portal.

The document is fully available here

Since February 13, 2022, single-use plastics products have faced a ban in Chile. Law 21.368 was published in August 2021 and aims to fight back the indiscriminate use of single-use plastics in different forms.

The single-use plastic restriction is only the start of an increasing effort to promote recycling and drive the country towards Circular Economy concepts. The recently published legislation also limits the generation of related disposable products, regulates plastics, and impose additional rules that will progressively enter into force.

In this respect, food retail establishments are forbidden to use and distribute single-use use products, such as glasses, cups, cutlery, chopsticks, stirs, mugs, straws, plates, goblets, boxes or food containers with foodstuff, trays, and sachets to be used in the business.

When consumers request a "to-go" meal, disposable products must be made of materials other than plastics, or be certified plastics in accordance with the Ministry of Environment certification guideline. The Ministry has 18 months to announce the regulation.

Beverage merchants must comply with a minimum percentage of recycled material when referring to the composition of plastic bottles, as well as offering returnable bottles scheme to consumers. The minimum recycled plastic content in bottles is to be successively implemented, not being less than 15% in 2025; 25% in 2030; 50% in 2040; 60% in 2050; and reaching 70% in 2060. In addition, manufacturers and importers are in charge of implementing awareness programs to promote recycling and the ecological impacts it may cause.

Any business that does not comply with the provisions is subjected to fines.

On February 28, 2022, the Secretariat of Infrastructure, Communications and Transportation (SCT) issued an Official Mexican Norm (NOM in Spanish). This regulation assigns specifications for transporting certain classes of dangerous goods, including consumer goods containing small quantities of hazardous substances. The aim is to establish new safety provisions.

NOM-011-1-SCT-2-2022 aligns the national standards with the international guidelines related to the transportation of excepted quantities of hazardous materials. The Official Mexican Norm reduces the transportation exigencies, consequently lowering cost and encouraging commercialization. It will also leverage the competition of the national products into international commerce. Concomitantly, NOM-011-1-SCT-2-2022 addresses labeling and packing of hazardous substances initially exempted from compliance with the NOM-002-SCT/2011 (due to exception quantities). They refer to NOM-002-SCT/2011’s column 7b:

Code

Maximum net amount per package/

inner package

Maximum net amount per package/outer box

E0

Transport is not allowed in the form of exception quantity

E1

30

1000

E2

30

500

E3

30

300

E4

1

500

E5

1

300

1 expressed in grams for solids and milliliters for liquids and gases; or the sum of grams and milliliters in the case of ordinary packaging

In the case of Explosives and Radioactive goods, they must also comply with the provisions of the Ministry of National Defense and the Ministry of Energy through the National Commission for Nuclear Safety and Safeguards, respectively. According to NOM-011-1-SCT-2-2022, the transport of hazardous substances and materials in excepted quantities and final consumption must be carried out based on their hazard classification and quantities to be transported.

NOM-011-1-SCT-2-2022 will enter into force 60 calendar days after its publication. And concerned businesses in Mexico need to fully comply.

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