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Top International News in Chemical Policy and Regulation: May 2018: Americas, Asia and Middle East

BRAZIL

Update on Status of Regulação de Substâncias Químicas Industriais (Industrial Chemicals Regulation) – The Brazilian Ministério do Meio Ambiente (Ministry of Environment; MMA), held its most recent meeting of the Comisión Nacional de Seguridad Química (National Commission of Chemical Safety; CONASQ) on February 22-23, 2018. The CONASQ meeting continued the previous process of discussing the 801 responses received in the public consultation related to the draft Regulação de Substâncias Químicas Industriais (Regulation) published on June 30, 2016.

Our MMA contact has estimated that they have discussed approximately 40 percent of all the comments received. Due in large part to this prolonged evaluation process, as well as current and upcoming legislative changes in Brazil, it is expected that the final version of the Regulation will not be presented for a vote in the Congress before the third quarter of 2018, if not later.

Brazil Issues Draft Resolution Regarding Toxicological Information For Pesticide and Related Products Labels -- Brazil’s Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency; ANVISA) has issued Draft Resolution N° 483, “Toxicological Information For Labels and Leaflets of Pesticides, Related Products and Wooden [sic] Preservatives.” Draft Resolution N° 483 sets out the obligatory information related to the protection of human health that must be included on pesticide labels and leaflets and similar products and wooden preservatives, as well as adopting the labeling guidelines of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The company is responsible for all labeling and package leaflet information, must present it clearly, and must ensure that it is adequate and sufficient for health protection purposes. In addition, ANVISA directs that the pictograms recommended by the Food and Agriculture Organization (FAO) of the United Nations (UN) should be used on pesticide labels and leaflets, as well as on wood preservatives.

Similar to the U.S. Environmental Protection Agency (U.S. EPA), ANVISA may, at its discretion and with a reasoned technical justification, require the company that holds the registration to change the texts of labels and package leaflets. Companies with already-registered pesticides and wood preservatives must comply with this Resolution, if/when final, up to 360 days after the enactment. Notably, such companies may implement the labeling and related changes without prior authorization from ANVISA.

ANVISA Amends 2015 Regulation Requiring Personal Care Products, Cosmetics, and Perfumes Registration -- Under its recently-published Draft Resolution Nº 500, ANVISA has amended Resolution RDC 7, of 10 February 2015, specifically Annexes II and VIII. Resolution RDC 7 established the personal care products, cosmetics, and perfumes that were subject to registration prior to commercialization. Most notably, the list of product types in Annex VIII that require registration has been reduced from 23 to eight. These eight are: tanning products, sunscreens, children’s sunscreens, antiseptic hand gel, hair straightening products, hair straightening and dyeing products, insect repellents, and infant insect repellants. Note that Draft Resolution Nº 500 does not necessarily group like products together (e.g., “sunscreens” and “children’s sunscreens” are two different categories in the Resolution.

CANADA

Canada Releases New Educational Primer On Chemical Regulations In Canada And The U.S.: On April 13, 2018, Environment and Climate Change Canada, Health Canada, and U.S. EPA published an educational primer on Canadian and U.S. regulations regarding new uses of chemical substances. The primer was developed by the Canadian and U.S. governments with a technical working group, comprised of industry and other stakeholders, acting as an advisory body. The information is organized by jurisdiction, beginning with significant new use rule (SNUR) program information, and followed by significant new activity (SNAc) provision details. Topics include: an overview of significant new uses/significant new activities; how individuals can determine if a SNUR/SNAc applies to their activities; where to find information about published SNURs/SNAcs, and notification requirements in the U.S. and Canada for SNURs/SNAcs.

Canada Amends Hazardous Products Regulations To Protect CBI: On April 18, 2018, Canada published a notice in the Canada Gazette amending the Hazardous Products Regulations. Under the amendment, if the concentration of a material or substance in a hazardous product must be provided on the safety data sheet (SDS) and the material or substance is always present at the same concentration, the SDS must provide:

  • The actual concentration of the material or substance in the hazardous product; or

  • One of the concentration ranges within which the actual concentration of the material or substance in the hazardous product falls.

If the concentration of a material or substance in a hazardous product is not always present at the same concentration, the SDS must provide:

  • The actual concentration range of the material or substance in the hazardous product;

  • One of the concentration ranges within which the actual concentration range of the material or substance in the hazardous product falls entirely; or

  • If the actual concentration range of the material or substance in the hazardous product is equal to or greater than 0.1 percent but less than or equal to 30 percent, and the actual concentration range does not fall entirely within any of the concentration ranges, a concentration range that is created by combining two consecutive ranges, provided that the combined concentration range does not include any range that falls entirely outside the actual concentration range in which the material or substance is present in the hazardous product.

If the SDS provides a concentration range, it must also provide a statement that the actual concentration range is withheld as a trade secret.

MEXICO

Ministry of Health Issues Draft NOM for Household Hygiene ProductsThe Mexican Ministerio de Salud (Ministry of Health) has issued a draft Norma Oficial Mexicana (NOM) affecting both those persons engaged in the processing or importation of hygiene products for household use, as well as the attendant labeling and packaging.

The “Proyecto de Norma Oficial Mexicana PROY-NOM-189-SSA1/SCFI-2016, Productos y Servicios. Etiquetado y Envasado Para Productos de Aseo de Uso Doméstico” (Draft Mexican Official Standard PROY-NOM-189-SSA1/SCFI-2016, Products and services. Labelling and Packaging for Hygiene Products for Household Use) establishes the requirements for both the health and commercial information with respect to the labeling of hygiene products for household use. The manifest purpose is to provide better customer choice to prevent their use from posing a risk to health.

Hygiene products (irrespective of their physical state) are defined in the NOM as substances intended for the washing or cleaning of objects, surfaces, or buildings, and substances that release a specific fragrance into the air. These products include soaps, detergents, cleaners, whiteners, starches for external use, stain-removers, disinfectants, deodorizers and air fresheners, and other similar products.

MIDDLE EAST

Four Middle Eastern Countries Incorporate GCC Technical RoHS-Type Regulation Into National Law -- The countries of Bahrain, Oman, Saudi Arabia, and the United Arab Emirates (a federation of seven emirates, comprised of Abu Dhabi (the capital), Ajman, Dubai, Fujairah, Ras al-Khaimah, Sharjah and Umm al-Quwain) have begun the process of incorporating the Gulf Cooperation Council’s (GCC) “Draft of GCC Technical Regulations for the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment” (Regulation) (Arabic only) into their respective national laws.

Through their respective legislative processes, Bahrain (via the Bahrain Standards and Metrology Directorate), Oman (via the National Enquiry Point and Information Centre), Saudi Arabia (via the Saudi Arabia Standards Organization), and the United Arab Emirates (via the Emirates Authority for Standardization and Metrology) are implementing the Technical Regulation that will apply to electrical and electronic equipment as defined in Annex (1) of the Regulation. Among such items are household appliances (large and small), IT and telecommunication equipment, consumer equipment, lighting, electrical and electronic tools, toys, and sporting equipment.

The Regulation sets out requirements on the restriction of the use of hazardous substances in electrical and electronic equipment, with a view to contributing to the protection of human health and the environment, including the environmentally-sound recovery and disposal of waste. These requirements must be met before such goods are made available in the GCC market.

TAIWAN

Taiwan EPA Begins Consultation On Proposed Revisions To Registration Regulations: On March 31, 2018, the Taiwan Environmental Protection Administration (Taiwan EPA) began a public consultation on proposed revisions to the regulations regarding registration of new and existing chemical substances. Taiwan EPA’s WTO notification states that the major amendments include:

  1. Clarifying the scope of application of the regulations. The regulations shall not apply to toxic chemical substances, as defined by the Toxic Chemical Substance Control Act (TCSCA);

  2. Harmonizing the information requirement between Taiwan EPA and the Ministry of Labor (MOL) regarding hazard assessment and exposure assessment;

  3. Issuing the registration number, instead of the registration document for the registration approved;

  4. Clarifying the quantity that triggers the obligation for the existing chemical substance phase 1 registration. For an existing chemical substance manufactured or imported in the annual volume of 100 kilograms (kg) or more, the phase 1 registration must be made within six months. Also a voluntary phase 1 registration may be made for the existing chemical substance manufactured or imported in the annual volume less than 100 kgs;

  5. Designating the first stage of 106 chemical substances subject to the standard registration of existing chemical substances;

  6. Clarifying the period of the information confidentiality of chemical substances included in the inventory of existing chemical substances, and ensuring consistency in the period of the information confidentiality and the validity of registration approval;

  7. Requiring an annual report of the new and existing chemical substances registered and approved. For chemical substances registered and approved, an annual report shall be completed from April to September each year;

  8. Indicating the calculation of the review period, so that the review period is calculated anew upon the registrant’s supplementation or modification of the registration application;

  9. Extending the limit on the time period and the number of times that a supplementation and correction may be made for a registration application, by taking into account the scientific and technical feasibility assessed by Taiwan EPA;

  10. Accepting written appeals with stated reasons for which the registrant may have concerns over the review result; and

  11. Deleting outdated provisions.

The list of 106 priority existing chemicals (PEC) is available in the English translation submitted to WTO. Comments on the proposed revisions are due May 29, 2018.

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The Acta Group (Acta®) is the consulting affiliate of Bergeson & Campbell, P.C. (B&C®), established to complement B&C’s legal services by providing a full-range of support for the process of marketing chemicals, biocides, and products of industrial biotechnology, nanotechnology, and synthetic biology. Acta knows that clients must function optimally in all jurisdictions in which they market and/or place products to remain competitive. We help them get there through our global reach....

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