March 2020

On December 20 2019, the U.S. Environmental Protection Agency (EPA) announced the next 20 chemicals to undergo risk evaluation under the amended Toxic Substances Control Act (TSCA).

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)

El 7 de febrero de 2020, el Gobernador del Estado de Nueva York firmó el proyecto de ley S.501B y anunció una nueva legislación para exigir a los fabricantes que revelen el uso de sustancias químicas en los productos infantiles. El Departamento de Conservación del Medio Ambiente (DEC) está obligado a hacer pública esta información a los consumidores. Esta ley entrará en vigor el 1 de marzo de 2020.

En la norma final, la información clave relacionada con la ley se resume a continuación:

• Define a los niños como "una persona o personas de doce años o menos".

• Define un producto infantil como "un producto destinado principalmente a los niños, fabricado para ellos o comercializado para su uso por niños".

• Requiere que el Departamento de Conservación del Medio Ambiente (DEC) publique listas de productos químicos peligrosos y productos químicos preocupantes en el sitio web del Departamento y revise la lista periódicamente con la consulta del Departamento de Salud.

• Cuando los productos infantiles contienen sustancias químicas peligrosas o preocupantes, los fabricantes están obligados a informar al DEC con la información que figura a continuación:

  1. Identificación del producto,

  2. Nombre de los productos químicos peligrosos o productos químicos preocupantes, incluidos, y, el

  3. Finalidad prevista de los productos químicos

• Los fabricantes están obligados a notificar a las personas que ofrecen los productos infantiles para su venta o distribución en el estado cuando el producto contiene sustancias químicas peligrosas.

• La DEC está obligada a notificar a los consumidores los productos infantiles que contengan sustancias químicas preocupantes y sustancias químicas peligrosas.

• A partir del 1 de enero de 2023, se prohibirá la venta de productos infantiles que contengan determinadas sustancias químicas peligrosas, como benceno, fosfato de tris (1, 3 dicloro-2-propilo), formaldehído (excepto en textiles), retardantes de llama organohalogenados y amianto.

On January 31, 2020, the Office of Health Hazard Assessment (OEHHA) published a proposed amendment to clarify the exposure warning requirements regarding internet and catalog sales activities.

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)

On January 3, 2020, the California Office of Environmental Health Hazard Assessment (OEHHA) added 2 new chemicals to the Proposition 65 List. The new chemicals are:

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:

In 1986, California voters approved an initiative titled California Proposition 65 to address their growing concerns about exposure to toxic chemicals. Since its origin, there have been many lawsuits that have resulted in reformulations of consumer products containing carcinogenic and reproductively harmful chemicals on the Cal Prop 65 list.

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

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

On January 16, 2020, the European Chemicals Agency (ECHA) added 4 new substances of very high concern (SVHC) to the SVHC Candidate List under Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). The added chemicals can be reproductive toxins as well as having persistent, bioaccumulative and toxic (PBT) properties. Their addition brings the total SVHC Candidate List to 205 substances.

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

On December 24, 2019, Turkey issued Regulation Number 30988 to further align the Turkey Toy Safety Regulation (Oyuncak Güvenliği Yönetmeliği, OGY) with the European Toy Safety Directive 2009/48/EC.

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.

On December 25, 2019, Turkey issued Notification No. 2019/43 and Notification No. 2019/44 to align the Turkey food contact plastics requirements with Regulation (EU) 10/2011.

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.

On January 20, 2020, the Bureau of Standards, Metrology and Inspection (BSMI) of Taiwan approved the proposal to introduce new certification requirements for children’s cots and folding cots.

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.

Due to the global virus conditions, Saudi Arabian Standards Organization (SASO) has extended the validity of product certificates registered in the SABER platform.

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.