March 2020 Regulatory Update

It is important to note that being designated as a high-priority chemical does not mean that a chemical is high risk. These chemicals will move through the process required by TSCA to evaluate any unreasonable risks they may present to human health or the environment.

The new 20 chemicals to be listed as high-priority chemicals are as follows:

• p-Dichlorobenzene (CAS: 106-46-7)
• 1,2-Dichloroethane (CAS: 107-06-2)
• trans-1,2- Dichloroethylene (CAS: 156-60-5)
• o-Dichlorobenzene (CAS: 95-50-1)
• 1,1,2-Trichloroethane (CAS: 79-00-5)
• 1,2-Dichloropropane (CAS: 78-87-5)
• 1,1-Dichloroethane (CAS: 75-34-3)
• Dibutyl phthalate (DBP) (1,2-Benzene- dicarboxylic acid, 1,2- dibutyl ester) (CAS: 84-74-2)
• Butyl benzyl phthalate (BBP) - 1,2-Benzene- dicarboxylic acid, 1- butyl 2(phenylmethyl) ester (CAS: 85-68-7)
• Di-ethylhexyl phthalate (DEHP) - (1,2-Benzene- dicarboxylic acid, 1,2- bis(2-ethylhexyl) ester) (CAS: 117-81-7)
• Di-isobutyl phthalate (DIBP) - (1,2-Benzene- dicarboxylic acid, 1,2- bis-(2methylpropyl) ester) (CAS: 84-69-5)
• Dicyclohexyl phthalate (CAS: 84-61-7)
• 4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA) (CAS: 79-94-7)
• Tris(2-chloroethyl) phosphate (TCEP) (CAS: 115-96-8)
• Phosphoric acid, triphenyl ester (TPP) (CAS: 115-86-6)
• Ethylene dibromide (CAS: 106-93-4)
• 1,3-Butadiene (CAS: 106-99-0)
• 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB) (CAS: 1222-05-5)
• Formaldehyde (CAS: 50-00-0)
• Phthalic anhydride (CAS: 85-44-9)

In the final rule, the key information related to the law is summarized below:

• Defines children as "a person or persons aged twelve and under."
• Defines a children's product as "a product primarily intended for, made for or marketed for use by children."
• Requires the Department of Environmental Conservation (DEC) to post lists of dangerous chemicals and chemicals of concern on the Department's website and review the list periodically with the consultation of the Department of Health.
• When children's products contain dangerous chemicals or chemicals of concern, manufacturers are required to report to the DEC with the information below:
  
  1. Identification of the product,
  2. Name of the dangerous chemicals or chemicals of concern, included, and, the
  3. Intended purpose of the chemicals


• Manufacturers are required to notify persons that offer the children's products for sale or distribution in the state when the product contains dangerous chemicals.
• The DEC is required to notify consumers about children's products containing chemicals of concern and dangerous chemicals.
• Starting as of January 1, 2023, the sale of children's products containing certain dangerous chemicals such as benzene, tris (1, 3 dichloro-2-propyl) phosphate, formaldehyde (other than in textiles), organohalogen flame retardants, and asbestos will be prohibited.

The key changes in the proposal are summarized below.

• Clarified the option of providing warnings via an electronic device or process that automatically provides the warning to the purchaser prior to or during the purchase of a product is only applicable at a “physical retail location."
• Included the sales activity through mobile device applications under the definition of “internet purchases" and corresponding exposure warnings requirements would be applied.
• Introduced the exposure warnings requirement for alcoholic beverages sold over the internet and in a catalog. The proposal offers a new option of delivering the exposure warning by email or text message.

The new amendment was under a public comment period until March 2, 2020.

1. Cannabis (marijuana) smoke
2. Δ9 -Tetrahydrocannabinol (Δ9 -THC)

The added chemicals meet the requirements for Prop 65 listing as known to the State of California to be a developmental hazard. The chemical details are provided below:

Recent settlements from July through December of 2019 include the following:

Recent 60-day notices from July through December of 2019 include the following:

The chemicals added are:

• Diisohexyl phthalate (CAS: 71850-09-4)
• 2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone (CAS: 119313-12-1)
• 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one (CAS: 71868-10-5)
• Perfluorobutane sulfonic acid (PFBS) and its salts

Key amendments to the current OGY are summarized below.

• New legal limit of 0.053 mg/kg for Chromium (VI) for material category III has been adopted
• Updated migration limits for lead in all three categories of toy materials
• Reduced the migration limit for bisphenol A (BPA) to 0.04 mg/l for toys intended for children under 36 months of age or other toys intended to be placed in the mouth
• Introduced Phenol content requirement for toys intended for children under 36 months or other toys intended to be placed in the mouth

The above new rules will be effective on December 24, 2020.

Notification No. 2019/44

• Technical equivalence to Commission Regulation (EU) No 10/2011 (except Annex III)
• General specifications of plastic food contact materials and articles, including overall migration and specific migration limit requirements
• Repealed Notification No. 2013/34 published in Official Journal No. 28710 dated July 17, 2013

Notification No. 2019/43

• Technical equivalence to Annex III of Commission Regulation (EU) No 10/2011
• Defines the food Simulants used in migration tests
• Repealed Notification No. 2013/35 published in Official Journal No. 28710 dated July 17, 2013

The above new rules will be effective on December 31, 2020.

Children’s cots and folding cots for domestic use with an internal length between 900 mm and 1400 mm shall be subject to the BSMI certification. Carry cots, cribs and cradles are excluded. The products concerned shall be tested according to CNS 11676:2019 Children's cots and folding cots for domestic use, which is based on the ISO counterpart ISO 7175:2019 (Parts 1 and 2).

For conformity assessment, products shall follow either the:

1. Batch-by-Batch Inspection (Type Approval); or
2. Registration of Product Certification (RPC) Scheme, which involves:
   
   • Product type-test by BSMI or BSMI-designated laboratories;
   • Product registration at BSMI; and
   • A Declaration of Conformity issued by the manufacturer or importer

A six month transitional period will be provided once the new requirements enter into force on March 1, 2020. Products are required to comply with the new rule when they are imported or placed on the Taiwan market starting from September 21, 2020.

Within its exceptional initiatives and in appreciation of the conditions of the traders and importers, as well as supporting the rapid entry of products into the Saudi market, SASO would like to announce the following initiatives:

• Extending the validity of all product certificates registered in SABER that will expire in the months of March, April or May 2020 for 3 more months from the expiration date of the certificate.
• Accepting the test reports that are issued by approved laboratories in the country of export up to 3 years, without the need to arrange new tests.

Thus, traders and importers are able to get the Shipment Certificate via SABER platform for the shipments that will be imported during this period of time based on the previous test reports and product certificates which its period will be extended automatically in SABER platform without the need to apply for renewal of the product certificates or conducting new test reports.