January 2023 Regulatory Update

In November 2022, Health Canada issued a notice to stakeholders about the consideration of substances for inclusion in future updates to the cosmetic ingredient hotlist, including new prohibitions and restrictions, as well as revisions to existing prohibitions and restrictions. The hotlist is a tool that Health Canada uses to communicate that certain substances, when present in a cosmetic, may conflict with the prohibition found in section 16 of the Food and Drugs Act (FDA) or a provision of the Cosmetic Regulations. Stakeholders are invited to provide information and proposals, but Health Canada will not provide any feedback or comments at this moment as the notice is intended to inform and is not part of a formal consultation process.

Details of the proposed updates are listed in the below table.

Those selling cosmetics in Canada should review their products to determine those that could be affected by the proposed updates, and plan ahead for any necessary changes to product formulations, distribution and sale.

The CPSC adopted ASTM F977-22e1 by reference to be the mandatory standard for infant walkers to replace ASTM F977-12. This final rule was published on 29 November 2022 and will go into effect beginning 25 February 2023.

Comparison and review of ASTM F977-12 to revisions contained in ASTM F977-22e1 are as follows:

1. Substantive Changes
1. Below test method is revised to use CAMI Infant Dummy Mark II to secure to the related position when conducting testing
1. Section 7.6.1.8, part of Test Platform Specifications, and Section 7.6.3.2, part of the Forward Facing Step Test
2. Section 7.6.4.2, part of the Sideward Facing Step Test
3. Section 7.6.5.2, part of the Rearward-Facing Step Test
2. Non-Substantive Changes include, but are not limited to:
1. Sections 7.3.2.3-7.3.3.5 replace wording in the Forward and Rearward Tip-Resistance test with language from ASTM F404-21, Standard Consumer Specification for High Chairs.
2. Section 7.6.4.1, part of the Sideward Facing Step Test, replaces “most sideward wheel(s)” with “wheel(s) closest,” for the Prevention of Falls Down Steps test.
3. Section 7.6.3.1, part of the Forward-Facing Step Test, adds a non-mandatory note: “To position the swivel wheels in the direction of movement, the walker should be positioned approximately 3 in. from the calculated release distance then moved parallel to Plane A until reaching the release point.”
4. Section 7.6.3.2, part of the Forward-Facing Step Test, adds the following notes: “When positioning the dummy in the seat, a length of military rope, as specified in Fig. 10, should be used to pull the front of the dummy's torso in contact with the front of the occupant seating area. The military rope must not restrain movement of the dummy's head per 7.6.1.8.” and “To hold the walker stationary, a mechanical device such as an archery bow release may be used to anchor the walker until it is released per 7.6.3.4.”
5. Adds notes to change incorrectly referenced sections.

Infant Walker manufacturers should immediately review their products, packaging and instruction manuals to ensure infant walkers imported to the US comply to the requirements of ASTM F977-22e1.

*Other Hazards include Ingestion Hazard, Injury Hazard, Poisoning Hazard, Health Risk Hazard and Carbon Monoxide Poisoning Hazard with a frequency of less than 2.

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*Other Hazards include Ingestion Hazard, Suffocation Hazard and Drowning Hazard with a frequency of less than 2.

*Other Categories include Tools and Hardware, Food Contact Material, Furniture, Sporting Goods / Equipment and Outdoor Living Items with a frequency of less than 2.

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In November 2022, the Southern Common Market (Mercado Común del Sur, Mercosur) issued Mercosur/GMC/Res. No. 26/22 to revise the “Mercosur Technical Regulation on Cellulosic Materials, Packaging and Equipment Intended to be in Contact with Food” (GMC Resolution No. 40/15). Member states including Argentina, Brazil, Paraguay and Uruguay are required to transpose the amendment into their national laws by 16 May 2023.

Under GMC Resolution No. 40/15, food contact cellulose materials and articles must not migrate any pigments and dyes according to testing to BS EN 646 “Paper and board intended to come into contact with foodstuffs – Determination of colorfastness of dyed paper and board”. The new amendment of the GMC Resolution establishes a grey scale of 5 for the migration of pigments and dyes from aforementioned materials when tested with the same test standard method.

Highlights of the changes in the amendment and comparisons are shown in the below table.

*Other Hazards include Electrical Shock Hazard, Fall Hazard, Amputation Hazard, Safety Risk Hazard, Skin Irritation Risk and Eye Irritation Risk with a frequency of less than 2.

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Under Commission Delegated Regulation (EU) 2020/217, the amendment of Regulation (EC) 1272/2008 on Classification, Labeling and Packaging of Substances and Mixtures – CLP Regulation, titanium dioxide in powder form containing 1% or more of particles with aerodynamic diameter is classified as a carcinogenic substance by inhalation. Products containing titanium dioxide should carry a warning label.

On 22 November 2022, the European General Court (ECG) has annulled the classification of titanium dioxide in such powder form as a carcinogenic substance under the Classification, Labeling and Packaging (CLP) Regulation. In the judgement, the ECG ruled that the Commission made a manifest error in the assessment of the reliability and acceptability of the study on which the classification was based and lead to incorrect classification criteria to be applied in the CLP Regulation to a substance that has intrinsic properties causing cancer.

Such a ruling will affect future decisions on classification and labelling as titanium dioxide is one of the most widely used pigments. The white pigment is commonly found in cosmetic products such as toothpaste and sunscreen.

On 21 December 2022, the European Chemical Agency (ECHA) initiated the first public consultation for the proposal on the restriction of bisphenol A (BPA) and other bisphenols with endocrine disrupting properties for the environment under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Annex XVII. The consultation on this proposed restriction started on 21 December 2022 and will end on 22 June 2023. The final opinion of ECHA is expected to be available by December 2023 at which time the opinion will be sent to the European Commission (EC) for making the decision on the inclusion of the proposed restriction under REACH Annex XVII.

Highlights of the proposed restriction are shown in the below table.

Specifications and information relating to charging interfaces applicable to certain categories or classes of radio equipment were introduced in Annex IA of Radio Equipment Directive (EU) 2022/2380, which amended Directive 2014/53/EU. The Amending Directive was published on 7 December 2022 in the Official Journal of the European Union. Included in the amendment are the following points:

1. This directive applies to these categories or classes of radio equipment: handheld mobile phones; tablets; digital cameras; headphones; headsets; handheld videogame consoles; portable speakers; e-readers; keyboards; mice; portable navigation systems; earbuds; laptops.
2. The radio equipment listed in point 1 which are capable of being recharged by means of wired charging shall:
1. be equipped with a USB Type C receptacle and cables which comply with standard EN IEC 62680-1-3 (Universal Serial Bus Interfaces for data and power - Part 1-3: Common components - USB Type-C® cable and connector specification).
2. incorporate the USB Power Delivery which complies with standard EN IEC 62680-1-2 (Universal Serial Bus interfaces for data and power - Part 1-2: Common components - USB Power Delivery Specification) if voltages are higher than 5 V, currents are higher than 3 A or powers are higher than 15 W.
3. Maximum power and minimum power for all categories or classes of radio equipment shall be described in text “the power delivered by the charger must be between min [xx] Watts required by the radio equipment, and max [yy] Watts in order to achieve the maximum charging speed.”
4. For categories or classes of radio equipment listed in point 2 b), “USB PD fast charging” and supported charging protocol shall be described.
5. Pictograms indicating whether a charging device is included with the radio equipment, label content related to “XX,” “YY” and “USB PD” and label appearance are now provided.

*Other Hazards include Entrapment Hazard, Suffocation Hazard, Microbiological Hazard, Environmental Hazard and Cut Hazard with a frequency of less than 3.

*Other Categories include Jewelry, Outdoor Living Items, Accessories, Footwear, Stationery, Tools and Hardware and Car Components with a frequency of less than 3.

*Other Countries include Latvia, Croatia, Slovakia, Norway, Denmark, Bulgaria and Estonia with a frequency of less than 4.

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The Standardization Administration of China issued a new national standard for the General Specification for Children's Cases and Bags (GB/T 41002-2022). This standard is applicable to cases and bags for children below the age of 14.

There are three categories under this standard according to the intended age of the end user:

• Category I: infants aged <36 months
• Category II: children aged 36 months to <6 years
• Category III: children aged 6 years to <14 years

Requirements: Products must comply with the labeling requirements and the technical requirements (material, chemical, physical and mechanical, appearance quality) stated in this standard, which include, but are not limited to:

• Designed pattern or logo requirement
• Ergonomic requirement
• Chemical requirement (Formaldehyde, Azo dyes, Phthalates, etc.)
• Appearance quality
• Colorfastness (to saliva, to rubbing, to alkaline perspiration)
• Corrosion resistance
• Retroreflective performance
• Seam strength
• Static pressure persistence on body of hard case
• Mileage test
• Jerking test
• Sharp points/sharp edges
• Expendable handle operation
• Metal wires or rods test
• Durability test (case-lock, fasteners, zippers, plastic buckle)
• Pulling rope
• Pompom
• Small parts
• Circular holes in rigid materials
• Stuffed materials
• Accessible clearances for movable segments

This new national standard was included in China’s No. 2 announcement of approved national standards in 2022 and went into effect on 1 October 2022.

The Ministry of Economic Affairs published a proposed amendment to the Standards on the Labeling of Toys on 2 December 2022. Comments will be accepted on the proposal until 3 February 2023. As outlined in the draft, the amended standard will go into effect on 18 May 2023.

The key proposals are as follows:

*Other Hazards include Entanglement Hazard, Damage to Sight, Electric Shock Hazard and Injury Hazard with a frequency of less than 2.

*Other Categories include Footwear and Electrical Appliances with a frequency of less than 2.

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