April 2019 Regulatory Update

NORTH AMERICA NEWS

US FDA Proposes Regulation to Control the Safety and Effectiveness of Sunscreens OTC Drug Products for Human Use

On February 21, 2019, the U.S. Food and Drug Administration (FDA) announced a proposed rule to update the regulatory requirements for sunscreen products in the US.

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With the aim to ensure that consumers can access safe and effective preventative sun care products from nonprescription, over-the-counter (OTC) channels, the FDA proposed to amend the regulatory requirements for sunscreen products using current scientific evidence and compliance with the Sunscreen Innovation Act (SIA). A summary of the proposed key updates is listed below:

  • Updated the list of safe sunscreen active ingredients
  • Updated the scope of dosage forms that are generally recognized as safe and effective (GRASE)
  • Proposed to raise the maximum SPF value on sunscreen labels from SPF 50+ to SPF 60+
  • Established broad-spectrum requirements for sunscreens with an SPF value of 15 or higher
  • Proposed new labeling requirement to help consumers identify key product information easily
  • Proposed that combination sunscreen with insect repellent products are not GRASE

The proposed amendments are under a comment period through May 28, 2019.


US FTC Seeks Public Comments on Leather Guides

On February 6, 2019, the U.S. Federal Trade Commission (FTC) published a notice to seek public comments on whether to repeal, amend or retain the Guides for Select Leather and Imitation Leather Products (Leather Guides) in 16 CFR 24.

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The Leather Guides, issued by the FTC in 1996, widely apply to the manufacture, promotion, and distribution of leather and imitation leather products including luggage, wallets and footwear. They provide instructions for the labeling of leather and imitation leather products. In addition, they address misrepresentations about the composition and characteristics of specific leather and imitation leather products and require marketers to deliver truthful, non-misleading information to consumers when selling imitation leather products.

The FTC seeks public comment on the continuing need for the Leather Guides through April 22, 2019.


US EPA Announces New Prioritization for Risk Evaluation of 40 Chemicals under TSCA

On March 20, 2019, the U.S. Environmental Protection Agency (EPA) published a notice to conduct a prioritization process for 40 selected chemicals under the amended Toxic Substances Control Act (TSCA).

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According to TSCA, the EPA is required to review chemicals currently in commerce on a regular basis. Among all 40 chemicals, 20 chemicals are classified as “High Priority Substances”, which required a subsequent three-year risk evaluation process to determine whether the chemicals pose hazards to human health and the environment. Twenty chemicals are classified as “Low Priority Substances” for risk evaluation.

A full list of the 40 chemicals included in the prioritization process can be found in the link below:
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/list-chemicals-undergoing-prioritization


US State of New York Proposes New Product Labelling Requirement Similar to California Proposition 65

On January 21, 2019, the State of New York proposed the Consumer Right to Know Act in the latest Executive Budget in order to protect the public from unknown exposure to toxic chemicals.

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In the proposal, a list of more than 1,000 carcinogens and other potential hazardous chemicals will be developed by the Department of Environmental Conservation (DEC), in consultation with the Department of Health and the Department of State. An on-package labelling requirement will be established to indicate the presence of the listed chemicals in consumer products.

Official legislative text has not yet been published. The government will work on measures to provide more information to consumers.


US State of California DTSC Proposes New Priority Product

In February, 2019, the California Department of Toxic Substances Control (DTSC) proposed to list toluene-containing nail products as a Priority Product with a Chemical of Concern under the Safer Consumer Products (SCP) Regulation.

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Toluene is a volatile solvent and commonly used in the manufacturing of nail products. Due to its high volatility at room temperature, toluene is readily released from products into the air causing inhalation, dermal and oral exposure. It has been found that exposure to toluene may pose adverse health effects in the nervous system and respiratory tract, as well as potentially cause developmental toxicity.

Upon approval, manufacturers of nail products containing toluene will be required to notify the DTSC within 60 days.


US State of California OEHHA Amends Proposition 65 NSRLs for Bromodichloroacetic acid and Bromochloroacetic acid

On February 5, 2019, the Office of Administrative Law (OAL) approved proposed amendments issued by the Office of Environmental Health Hazard Assessment (OEHHA) regarding the addition of No Significant Risk Levels (NSRLs) for the chemicals, Bromochloroacetic Acid and Bromodichloroacetic Acid in Title 27, California Code of Regulations, section 25705.

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Bromochloroacetic Acid and Bromodichloroacetic Acid are carcinogens that are listed on the Proposition 65 Chemical list. For determining the safe harbor level of carcinogens in the environment, NSRLs are developed by the OEHHA. Daily exposure to carcinogens below corresponding NSRLs is considered to pose no significant risk to human health and therefore no Proposition 65 warning label is required.

According to the Final Statement of Reasons (Bromochloroacetic Acid and Bromodichloroacetic Acid), the following NSRLs came into force on April 1, 2019.


Chemical CAS number NSRL
Bromodichloroacetic acid 71133-14-7 0.95 micrograms per day
Bromochloroacetic acid 5589-96-8 0.70 micrograms per day

US State of California OEHHA Adds New Chemical to Proposition 65 List

In March 2019, the California Office of Environmental Health Hazard Assessment (OEHHA) added a new chemical to the Proposition 65 List. The new chemical is:

  • Bevacizumab

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The added chemical meets the requirements for listing under Proposition 65 as being known to the State of California to cause developmental toxicity and female reproductive toxicity. The chemical details are provided below:

Date of addition Chemical Chemical Abstracts Service Number (CAS No.) Types of Toxicity
March 8, 2019 Bevacizumab 216974-75-3 Developmental toxicity
Female reproductive toxicity

Health Canada Publishes Updated Guidance for Children’s Sleepwear Regulations

In February 2019, Health Canada published updated guidelines for the Children’s Sleepwear Regulations (SOR/2016-169).

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These guidelines provide information about flammability safety requirements for children’s sleepwear in sizes 0 to 14X, including bathrobes, sleepers and nightgowns that are manufactured, imported, advertised or sold in Canada. The following key updates are included in the new version of the guidelines:

  • Updated the definition of children’s sleepwear
  • Added interpretation of sizing of children’s and adult’s sleepwear
  • Added guidance for sleepwear accessories, including slippers, sleep masks and caps
  • Amended sizing for infants age 9 months and interpretation for Infant styling up to 9 months
  • Specified the labeling criteria size labelling
  • Updated flammability requirements for tight-fitting and loose-fitting children's sleepwear
  • Updated the requirements for the use of flame-retardant chemicals in children’s sleepwear

Health Canada Proposes to Amend the Toys Regulations

In February 2019, Health Canada issued a notice to amend the Toys Regulations (SOR/2011-17) by adding new flammability and labelling requirements for play tents.

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Recently, Health Canada proposed an update to current flammability and labelling requirements in the Tents Regulations to address the flammability risk of tents found in the Canadian market. (See Regulatory Recap: March 2019). As a result of those proposed updates, certain play tent requirements shall be incorporated into the Toys Regulations as noted below:

  • Amendment of Toy Regulations to include new flammability and fire safety labelling requirements for play tents intended for indoor use only.
  • Considering new warning statements "Warning! Keep away from open flame." and "For indoor use only!" to be required on play tents.
  • Proposal to prohibit or restrict the use of flame retardants in tents, play tents and possibly other toys subject to flammability requirements.

The comment period for the proposed amendments ended March 23, 2019.


AUSTRALIA AND NEW ZEALAND NEWS

Australia Amends Prams and Strollers Safety Standard

On February 14, 2019, the Commonwealth of Australia published an Amendment on Safety Standard for Prams and Strollers to expand the scope of strollers in the standard.

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According to the amendment, the following statement was introduced to the scope of Consumer Product Safety Standard for Prams and Strollers:

“Strollers include wheeled vehicles that can operate in more than one mode, if one of those modes is designed to transport a child in a seated position (including, but not limited to, convertible tricycle strollers).”

The amendment came into force on February 14, 2019.


Australia and New Zealand Propose Adoption of International Standard for Toys Mechanical and Physical Safety Requirements

On February 26, 2019, Australia/New Zealand Standards issued a Notice of Intention to adopt the international toy safety standard, ISO 8124-1:2018, Safety of toys — Part 1: Safety aspects related to mechanical and physical properties.

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The aim of the standard is to specify safety aspects related to the mechanical and physical properties that are generally applicable to toys for children up to the age of 14 years, taking into account normal use and reasonably foreseeable abuse. This standard will be identical to ISO 8124‑1:2018.

The public comment period for this proposal ended April 9, 2019.


EUROPE NEWS

ECHA Proposes Amendment of Annex XVII List of Restriction by Introducing 12 New Chemicals

On February 12, 2019, the European Chemical Agency (ECHA) proposed to amend Annex XVII of Regulation (EC) No. 1907/2006 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) through World Trade Organization (WTO) notification.

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Upon enforcement, the proposed amendment adds the following substances to Annex XVII of REACH Regulation List of Restriction:

  • 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear;
  • Dihexyl phthalate;
  • 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate;
  • Trixylyl phosphate;
  • Sodium perborate, perboric acid, sodium salt;
  • Sodium peroxometaborate;
  • 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] (covering any of the individual stereoisomers of [1] and [2] or any combination thereof) ('karanal group');
  • 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328);
  • 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327);
  • 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350);
  • 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320);
  • Diazene-1,2-dicarboxamide (C,C'-azodi(formamide)) (ADCA)

REACH – Proposal to Include New SVHCs on Candidate List

On March 13, 2019, the European Union (EU) proposed to amend Annex XIV of Regulation (EC) No. 1907/2006 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

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Upon enforcement, the proposed regulation will amend the Annex XIV List of Authorised Chemicals by adding the following 3 substances of very high concern (SVHC).

  • 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoic acid, its salts and its acyl halides (covering any of their individual isomers and combinations thereof)
  • 2-methoxy ethyl acetate (EC 203-772-9, CAS 110-49-6).
  • Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥0.1 % w/w of 4-nonylphenol, branched and linear (4-NP)

The proposed amendment is under a comment period through April 29, 2019.


EU Publishes New Standards for Food Contact Paper and Paperboard

On February 28, 2019, the European Committee for Standardization (CEN) announced new versions of food contact paper and paperboard standards relating to colorfastness, fluorescent fastness and antimicrobial constituents testing.

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Below is a summary of the new standards for food contact paper and paperboard:

Current standard New standard Details
EN 646: 2006 EN 646:2018 Determination of colorfastness in food contact dyed paper and board
  • Introduces new test fluid, “alkaline salt solution” to replace previous test fluid, “saliva simulant”
  • Adds 2 new test conditions to simulate different usage conditions of paper and paperboard materials
    Test condition Food contact condition
    Procedure A
    24 h at (23 ± 2) °C
    Long duration contact
    Procedure B (new condition)
    4 h at (23 ± 2) °C
    Medium time contact
    Procedure C
    10 min at (23 ± 2) °C
    Short time contact
    Procedure D (new condition)
    30 min at (120 ± 3) °C in oil
    30 min at (90 ± 3) °C in water
    Hot fatty and moist food contact
  • Introduces different glass fiber papers for testing purposes
  • Only gray scale is accepted in the result evaluation
EN 648:2006 EN 648:2018 Determination of the fastness of fluorescent whitened paper and board
  • Introduces new test fluid, “alkaline salt solution” to replace previous test fluid, “saliva simulant”
  • Adds 2 new test conditions to simulate different usage conditions of paper and paperboard materials
    Test condition Food contact condition
    Procedure A
    24 h at (23 ± 2) °C
    Long duration contact
    Procedure B (new condition)
    4 h at (23 ± 2) °C
    Medium time contact
    Procedure C
    10 min at (23 ± 2) °C
    Short time contact
    Procedure D (new condition)
    30 min at (120 ± 3) °C in oil
    30 min at (90 ± 3) °C in water
    Hot fatty and moist food contact
  • Introduces different glass fiber papers for testing purposes
EN 1104:2005 EN 1104:2018 Determination of antimicrobial constituents in food contact paper and board
  • Updates the definition of “Inhibition Zone”
  • Increases the number of samples to 9 for assessment

Conflicting national standards will be withdrawn by May 2019.


ASIA NEWS

India Publishes New Legislation for Food Contact Materials and Articles

On January 3, 2019, the Food Safety and Standard Authority of India (FSSAI) published the Food Safety and Standards (Packaging) Regulation, 2018 to replace the Food Safety and Standards (Packaging and Labelling) Regulation 2011. New labelling regulations were published separately.

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The new regulations include both general and specific requirements for packaging materials. “Packaging material” in the new regulations is defined as materials such as cardboard, paper, glass, metal, plastic, and multi-layer packaging material used for the packaging of food products. A summary of important provisions of the new regulations follow:

  • Prescribes an overall migration limit and specific migration limits for plastic packaging materials.
  • Specifies that food packaging materials must comply with India Standards (IS) listed in the Schedules of the new regulations.
  • Requires printing inks for use on food packages comply with IS 15495.
  • Specifies a list of suggested packaging materials in Schedules for various categories of food product.
  • Bans the use of recycled plastic and newspaper as food packaging materials.
  • Allows use of relevant international standards where Indian Standards are not available.
  • Requires all business operators to obtain a Certificate of Conformity (CoC) issued by laboratories.

The new regulations come into force on July 1, 2019.


Taiwan Proposes Amendment to the Inspection Requirements for Sunglasses and Lenses of Sunglasses

In March 2019, the Taiwan Bureau of Standards, Metrology and Inspection (BSMI) announced a proposal through World Trade Organization (WTO) notification to update current mandatory inspection requirements for sunglasses and lenses of sunglasses.

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As proposed in the amendment notification, inspection standard CNS 15067 will be updated to its 2017 version. Updates to the requirements include aspects of transmittance, spectral transmittance, detection of light signal etc. The Declaration of Conformity and relative conformity assessment procedure remains unchanged.

A summary of covered products and their applicable inspection standards is shown below:

Product category Reference C.C.C code Inspection Standard after amendment
Sunglasses (inspection scope: nonprescription sunglasses for sun glare filters for general use, polarizing filters and gradient filters) 9004.10.00.00.6 CNS 15067 - 2017
Spectacle lenses of glass (inspection scope: nonprescription shaped and finished lenses of sunglasses) 9001.40.00.00.3
Spectacle lenses of plastics (inspection scope: nonprescription shaped and finished lenses of sunglasses) 9001.50.00.10.8

The proposed amendments come into force on March 1, 2020.


SASO NEWS

EER Enforcement Schedule Update for Washing Machine and Refrigerator

On February 20, 2019, SASO issued a notice to certification bodies regarding the update of implementation plans for 1) Washing Machines and 2) Refrigerators/Freezers

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The summary of the updates are as follows:

Enforcement Day Implementation Plan for Refrigerator and Freezer
December 31, 2019 Expiration of all Refrigerators, Refrigerator-Freezer and Freezers licenses with class E and F
January 1, 2020 Refrigerators, Refrigerator-Freezer and Freezers with class’ E’ and ‘F’ are not allowed in the market (Phase 2)
January 1, 2021 Implementation of phase 2 on market and initiation of market surveillance

Enforcement Day Implementation Plan for Washing Machines
Currently enforced Washing machines shall have minimum energy efficiency ratings as stated below for entering the market:
  • Twin tubs: Class G
  • Top loading: Class F
  • Front Loading: Class E
September 30, 2020 Expiration of all Washing Machine licenses lower than class E
October 1, 2020 All washing machines shall have a minimum efficiency rating of ‘Class E’ to enter the market.
  • Twin tubs: updated from Class G to Class E
  • Top loading: updated from Class F to Class E
  • Front loading: Class E (No update) Implementation of Phase 2 on market and initiation of market surveillance
October 1, 2021 Market surveillance will be commenced by Ministry of Commerce and SASO to verify the implementation of the new EER label design and regulations

CITC Updates Requirements to UMTS and LTE Handsets and Ancillary Equipment

On March 21, 2019, the Communication and Information Technology Commission (CITC) issued a notice regarding the latest requirements for Universal Mobile Telecommunication System (UMTS) and LTE handsets and ancillary equipment that are intended for importation into Saudi Arabia.

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The notice states that all equipment falling within the scope of CITC technical specification RI056, namely UMTS and LTE handsets and related terminal equipment, are required to at least support 4G and contain an CITC E-label to receive approval from CITC and enter into Saudi Arabia. The CITC has also cancelled all prior approved certificates for devices that fall within the scope of technical specification RI056 but do not support 4G.


SASO Imposes Temporary Change to Requirements on EER Registration of Lighting Products

On April 2, 2019, the Saudi Standards, Metrology and Quality Organization (SASO) announced that until the end of this year, they are accepting Energy Efficiency Certificate and Labelling (EER) registration of lighting products that have not completed the 2000 hours survival factor and lumen maintenance test.

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SASO requires lighting products to comply with the EER requirement for entering Saudi Arabia. To obtain the EER certificate, reports for survival factor and lumen maintenance test of at least 2000 hours are required. In a notice dated April 2, 2019, SASO agreed to accept EER registration for lighting products that have not obtained the aforementioned reports, given the following conditions:

  • For lamp products:
    • Provide document from manufacturer agreeing to perform the test and submit the test report to SASO within 15 days of the completion of the test.
    • Provide document from SASO accredited third party laboratory confirming receipt of samples and indicating start and end date of test.
  • For luminaries products:
    • Provide document from manufacturer agreeing to perform the test and submit the test report to SASO within 15 days of the completion of the test.
    • Provide document from SASO accredited third party laboratory confirming receipt of samples and indicating start and end date of test if testing is performed by a SASO accredited third party laboratory.
    • Provide contract with third party for performing witness tests clarifying the start and end dates of the test if testing is performed by a SASO accredited manufacturer’s laboratory.

SASO may take legal procedures if manufacturer or supplier fails to submit test report within 30 days of the completion of the test.


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