April 2016

El 1 de abril de 2016, la Oficina de Evaluación de Peligros para la Salud Ambiental (OEHHA) emitió un aviso, Aviso de Acción de Emergencia para Modificar la Sección 25603.3 Título 27, Código de Regulaciones de California Advertencias para Exposiciones al Bisfenol A de Alimentos y Bebidas Enlatados o Embotellados, para proponer el uso temporal de un mensaje de advertencia estándar en el punto de venta para el Bisfenol A (BPA) para alimentos y bebidas enlatados y embotellados. El mensaje de advertencia propuesto pretende evitar mensajes de advertencia incoherentes, reducir la posibilidad de confusión entre los consumidores y protegerlos de la toxicidad reproductiva del BPA. El BPA se añadió a la lista de la Proposición 65 el 11 de mayo de 2015 y su requisito de advertencia comienza un año después(véase Recapitulación normativa: número 2, mayo de 2015). Mientras tanto, en un proceso de reglamentación separado, la OEHHA propone un Nivel de Dosis Máxima Permitida (MADL) de BPA para la exposición dérmica, pero no para la exposición oral al BPA de alimentos y bebidas. Por lo tanto, el MADL no cubre el revestimiento de resina epoxi utilizado en latas metálicas de alimentos y bebidas. Los productos con revestimientos de resina epoxi pueden causar exposición al BPA y pueden requerir una advertencia.

Una vez que entre en vigor el requisito de la etiqueta de advertencia, los minoristas podrán poner advertencias en todos los alimentos y bebidas que puedan contener BPA, mientras que otros podrán advertir de forma selectiva e inconsistente. Esto se debe al hecho de que los alimentos enlatados y embotellados generalmente tienen una vida útil de hasta 3 años y la actual normativa de advertencia de la Propuesta 65 se aplica a los productos producidos después de mayo de 2015. Con un período de transición de 1 año, todavía hay un volumen significativo de productos en stock fabricados o producidos antes de mayo de 2015 que permanecen en los estantes sin advertencias.

Actualmente, no existe ningún requisito normativo para que la advertencia de la Propuesta 65 mencione la sustancia química o su efecto asociado sobre la salud. Algunas empresas pueden optar por nombrar el BPA en su mensaje de advertencia y proporcionar información complementaria sobre el BPA, mientras que otras pueden limitarse a decir que "el producto alimenticio o bebida contiene una sustancia química conocida por el Estado de California por causar defectos de nacimiento u otros daños reproductivos". Estos mensajes generales pueden causar confusión entre los consumidores y no sirven al interés público.

A la luz de estas preocupaciones, el uso temporal de un mensaje de advertencia estándar y uniforme en el punto de venta para el BPA abordaría los problemas y evitaría la confusión pública resultante de mensajes de advertencia incoherentes.

On January 27, 2016, Assembly Bill 1821, 2014 was re-introduced as Assembly Bill 1437, 2016 to propose an act related to bisphenol A (BPA). The bill would prohibit the sale and distribution of food and beverage packaging and containers made with BPA as well as food and beverage storage containers made with BPA. The re-introduced bill is identical to the previous bill. Once the bill is passed and signed into law, this act will be effective immediately.

A storage container here means any refillable or reusable plastic container which may be used for reheating or storage of food and beverage, for examples:

1. Thermoses

2. Baby bottles

3. Coolers

4. Resealable containers

On February 24, 2016, the Public Safety and Security Committee introduced House Bill No. 5404 "An Act Concerning Toxic Flame Retardant Chemicals in Children's Products and Furniture". The proposed act would prohibit children's products and upholstered residential furniture from containing certain flame retardant chemicals. The implementation of prohibition is divided into 2 phases with the same flame retardants being prohibited:

1. Starting from July 1, 2019, manufacturers, wholesalers or distributors shall not manufacture, sell or distribute children's product or upholstered residential furniture containing 1000 ppm of the above flame retardants in any product component.

2. Starting from July 1, 2020, retailers shall not sell children's product or upholstered residential furniture containing 1000 ppm of the above flame retardants in any product component.

On March 17, 2016, bill B21-0143 was signed and enacted with act number A21-0336, "Carcinogenic Flame Retardant Prohibition Amendment Act of 2016". This act amends Human and Environmental Health Protection Act of 2010 to prohibit the manufacture, sale and distribution of any product containing certain chlorinated flame retardants. According to the amended act, the implementation of prohibition is divided into 2 phases with the same flame retardants being prohibited:

1. Starting from January 1, 2018, no person can manufacture, sell or distribute any children's product or residential upholstered furniture containing more than 0.1% (1000 ppm) of the above flame retardants.

2. Starting from January 1, 2019, no person can manufacture, sell or distribute any product containing 0.1% (1000 ppm) of the above flame retardants.

The Mayor may request the manufacturer to provide a certificate demonstrating compliance with the act in 45 days. Otherwise, the manufacturer shall notify persons or entities, who sell and distribute the product, that the product does not comply with the act and submit a list of the names and addresses of those notified.

On March 10, 2016, the Washington House Bill, HB 2545 to amend the Children's Safe Product Act (CSPA) Chapter 70.240 RCW was approved by the president of the Washington State Senate. The amendment adds restrictions on flame retardant chemicals in children's products and residential upholstered furniture. Also, the Department of Ecology (DoE) will consider to include other unrestricted flame retardants as Chemicals of High Concern to Children (CHCC). Once the bill is signed into law, manufacturers, wholesalers or retailers shall not manufacture, sell or distribute children's products and upholstered furniture containing flame retardants starting from July 1, 2017. The restricted concentration is 1000 ppm in any product component and the restricted flame retardants include:

A manufacturer of products that are restricted (containing listed flame retardants at greater than 1000 ppm) must notify persons who sell the manufacturer's products before April 2, 2017.

Apart from restriction of the above 5 flame retardants, a new section was added to CSPA addressing that the DoE shall consider whether the following flame retardants meet the criteria of being a CHCC:

If any of the above flame retardants is identified as a CHCC, the Department of Health shall create an advisory committee. The committee will determine the necessity to restrict and prohibit the flame retardants identified from being used in children's products and residential upholstered furniture.

On March 7, 2016, the President of the National Institute of Metrology, Quality and Technology (INMETRO) approved Administrative Rule No. 99 to restrict toys including "AquaDots" and "Bindeez" that containing 1, 4-butanediol. The draft of this administrative rule was proposed on December 17, 2015 (See Regulatory Recap: February 2016). The approved rule is identical to the draft. Beginning March 7, 2016, all toys including or similar to "AquaDots" and "Bindeez" containing 1,4-butanediol are prohibited. Manufacturers and suppliers of such toys shall immediately withdraw them from the market.

On March 9, 2016, European Commission (EC) approved the Regulation (EU) 2016/425 Personal Protective Equipment. This new regulation will repeal the Council Directive 89/686/EEC on April 21, 2018 and enter into force on the same date. The regulation adopts and simplifies certain essential safety requirements from Directive 89/686/EEC and lays down requirements for the design and manufacture of Personal Protective Equipment (PPE). Manufacturers, distributors and importers of PPE are impacted by this new regulation. Some PPE products that are excluded from the previous Directive are now incorporated into the new PPE Regulation in order to ensure a high level of protection to the user. The newly added products are as follows:

1. PPE that is designed for private use against heat, such as gloves

2. PPE for self-defense in sport activities

The new regulation divides PPE's into 3 risk categories and it is the responsibility of manufacturer to carry out a risk assessment in order to identify the risks for the PPE:

1. Category I: Minimal risks, such as

   • Superficial mechanical injury

   • Contact with cleaning materials of weak action or prolonged contact with water

2. Category II: Risks other than those listed in Categories I and III

3. Category III: Risks that cause very serious consequences, such as

   • Falling from a height

   • Substances and mixtures which are hazardous to health

The compliance requirements for the 3 categories are summarized in the below table:

Apart from the manufacturers' responsibilities, importers and distributors shall ensure that their PPE is compliant with this regulation, bears the CE marking and is accompanied with required documentation.

On March 30, 2016, European Commission (EC) approved Regulation (EU) 2016/460 to amend annex IV and V of Regulation (EC) No. 850/2004 Persistent Organic Pollutants (POPs). The amendment will become effective on September 30, 2016.

The highlights of the amendments is listed below:

1. In Annex IV which lists substances that are subject to waste management provisions, one new entry is added:

2. Part 2 of Annex V, Wastes and Operations, is amended as follows:

Maximum concentration limits of substances are also added:

On March 14, 2016, the European Union (EU) published a draft directive regarding the use of bisphenol A (BPA) in varnishes and coatings intended to come into contact with food. The scope of the BPA prohibition in food contact materials or articles is proposed to expand by establishing a migration limit regarding varnish or coating materials that come into contact with food. The Specific Migration Limit (SML) of BPA is proposed to be lowered in Regulation (EU) No. 10/2011 on Plastic Materials and Articles intended to Come into Contact with Food.

BPA has widely been used in epoxy resins for varnishes and coatings on food cans. Food is possibly exposed to BPA and therefore EU proposes to establish a SML for BPA in varnishes and coatings to ensure a high level of protection to humans. In light of this, a SML of 0.05mg/kg has been proposed. Also, business operators shall ensure that a written declaration of compliance is available for the varnished or coated materials and articles.

While the SML of BPA under Regulation (EU) No. 10/2011 is proposed to be revised from 0.6 mg/kg to 0.05 mg/kg. The BPA requirement for polycarbonate infant feeding bottles will remain unchanged.

On June 13, 2016, the Directive 2014/53/EU Radio Equipment (RE Directive) will enter into force. European marketed radio products that currently comply with the Directive 1999/5/EC Radio & Telecommunication Terminal Equipment (R & TTE Directive) will now have to comply with the new RE Directive. The R & TTE Directive will be repealed on the same date.

The RE Directive is similar to the R & TTE Directive with a change in the scope. The scopes of both Directives are summarized below for comparison:

There are 3 essential requirements in the RE Directive,

1. Radio equipment shall comply with following Directives:

   1. Directive 2014/30/EU: Harmonization of the Laws of the Member States Relating to Electromagnetic Compatibility

   2. Directive 2014/35/EU: Harmonization of the Laws of the Member States Relating to the Making Available on the Market of Electrical Equipment Designed for Use within Certain Voltage Limits

2. Radio equipment shall be used effectively and it shall supports the efficient use of radio spectrum in order not to produce harmful interference

3. It shall also meet the other essential requirements in RE Directive

Manufacturers shall perform a conformity assessment and it can be carried out by any one of the following procedures:

On February 29, 2016, the European Union (EU) member states proposed to identify four new chemicals as Substances of Very High Concern (SVHC) under the REACH Regulation with carcinogenic, mutagenic, toxic to reproduction, persistent, bioaccumulative and toxic, and very persistent and very bioaccumulative properties. The public consultation ended on April 14, 2016.

The four chemicals proposed are:

1. (±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptane-2-one (4-methylbenzylidene camphor) (EC No. 253-242-6) (CAS No. 36861-47-9);

2. 1,7,7-trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one (3-benzylidene camphor) (EC No. 239-139-9) (CAS No. 15087-24-8);

3. Benzo[def]chrysene (Benzo[a]pyrene) (EC No. 200-028-5) (CAS No. 50-32-8);

4. Dicyclohexyl phthalate (DCHP) (EC No. 201-545-9) (CAS No. 84-61-7)

On January 1, 2016, the General Directorate for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF) implemented a new Methodological Document, DM/4B/COM/001, for food contact materials which are made from metals or alloys. Mandated requirements have been established and summarized in 9 categories of metals and alloys.

In the document, composition, purity and Specific Migration Limits (SML) requirements for certain elements or chemical species have been listed in detail. Different types of metals and alloys will have specific requirements:

1. Stainless steel

2. Aluminium and aluminium alloys

3. Steel for Packaging

4. Uncoated steel including packaging

5. Steel and Stainless steel excluding packaging

6. Unalloyed iron

7. Tin and Tin alloy

8. Zinc and Zinc alloy

9. Various metal coated objects

It should be noted that these requirements are not applicable to:

1. Enamel materials

2. Inorganic coated materials

3. Organic mineral coated materials, such as sol-gels coating

The definitions for different alloys and testing conditions, such as simulants, temperatures and durations, are also included in the document.

On October 27, 2015, China proposed a draft GB National Standard: Sunglasses and Sunglare Filters - Part 1: General Requirements. The technical requirements in the standard are modified from ISO 12312-1: 2013, Eye and Face Protection - Sunglasses and Related Eyewear - Part 1: Sunglasses for General Use.

Compared with ISO 12312-1: 2013, the major technical differences with the GB standard are:

1. Cancelled ISO12312-1: 2013 clause 6.2 Local Variations in Refractive Power

2. Modified ISO 12312-1: 2013 clause 7 Robustness

3. Added solar spectral transmittance requirements for wavelength lower than the cutoff

4. Added transmittance requirements for prescribed correction sunglasses and sunglare filters

5. Added coating layer adhesion requirements

Following requirements are mandatory while the others (not stated here) are optional:

• Clause 6.1 Transmittance

• Clause 6.2 Optical Properties

• Clause 6.3 Endurance of sunglasses

• Clause 6.4 Frame deformation and retention of filters

• Clause 6.5 Resistance to solar radiation

• Clause 6.6 Resistance to ignition

• Clause 6.7 Coating layer properties

• Clause 6.8 Size of sunglasses

• Clause 7.1 Labeling requirements

On February 4, 2016, Japan proposed to add a new item in the Japan Food Sanitation Law (JFSL) regarding utensils, containers and packaging made of synthetic resin, PolyEthylene Naphthalate (PEN).

According to the proposed document, PEN materials shall not be used or marketed as a utensils, containers and packaging for food unless they meet following requirements:

1. Specific Migration Limit (SML) of Germanium (Ge) less than 0.1 mg/L (using 4% acetic acid as a stimulant)

2. Evaporation residue less than 30 mg/L

On December 4, 2014, The Notification of Ministry of Public Health No. 367, Labeling of Prepackaged Foods, entered into force. The notification gave a 2-year transition period to all manufacturers or importers of food. On or before December 4, 2016, manufacturers or importers of food must comply with the new labeling contents and requirements stated in this notification for prepackaged foods, which are defined as foods packed in containers for sale.

In general, the food labeling shall be in Thai and the following information shall be presented (specific requirements on each item shall be referred to in the notification):

1. Name of food

2. Food serial number

3. Name and address of manufacturers, packers or importers

4. Contents of food

5. Percentage by weight of main ingredients

6. Information regarding food allergy or hypersensitivity

7. Declaration of functional class of food additives according to International Numbering System (INS) for Food Additives

8. Declaration of addition of food additives

9. Shelf life

10. Any warning statement, instruction for storage, cooking and use

Apart from labeling, the following older notifications concerning prepackaged food labeling are repealed:

1. The Notification of Ministry of Public Health No. 194 Labels

2. The Notification of Ministry of Public Health No. 252 Labels

3. The Notification of Ministry of Public Health No. 343 Labels

El 19 de marzo de 2016 entró en vigor una prohibición provisional de 60 días para el suministro de hoverboards, también conocidos como patinetes autoequilibrados, que no cumplan requisitos de seguridad específicos. Esta prohibición afecta a todos los proveedores de hoverboards, incluidos fabricantes, importadores, distribuidores y minoristas.

A continuación se enumeran las normas y requisitos de seguridad específicos para los hoverboards:

El 18 de abril de 2016 entra en vigor el nuevo Reglamento sobre normas de seguridad de los productos (ropa de dormir para niños y ropa de día limitada con riesgo de incendio reducido) de 2016. El reglamento adopta la norma actualizada AS/NZS 1249: 2014 Children's Nightwear and Limited Daywear Having Reduced Fire Hazard y derogará los reglamentos anteriores publicados en 2008 con el mismo título(véase Recapitulación normativa: marzo de 2016).

El nuevo reglamento aprobado sustituirá al de 2008 el 17 de abril de 2017 y aborda cuestiones de inflamabilidad y seguridad relacionadas con la ropa de dormir infantil. Existe un periodo de un año para la transición de la normativa de 2008 a la de 2016. Por lo tanto, una persona puede cumplir con la versión 2003 o 2014 de la norma AS/NZS 1249 para los productos antes del 17 de abril de 2017.

Nota: la Comisión Australiana de Competencia y Consumo (ACCC) aún no ha adoptado la norma actualizada. Los productos comercializados en Australia seguirán cumpliendo la norma AS/NZS 1249:2003 hasta que la ACCC publique una actualización.