April 2016 Regulatory Update

BPA was added to the Proposition 65 List May 11, 2015 and its warning requirement begins 1 year thereafter (See Regulatory Recap: Issue 2, May 2015). Meanwhile, in a separate rulemaking process, OEHHA is proposing a BPA Maximum Allowable Dose Level (MADL) for dermal exposure but not for oral exposure to BPA from food and beverages. Therefore, the MADL does not cover the epoxy resin lining used in metal-based food and beverage cans. Products with epoxy resin linings can cause exposure to BPA and may require a warning.

Once the warning label requirement goes into effect, retailers may put warnings on all food and beverage products that may contain BPA, while others may warn selectively and inconsistently. This is due to the fact that canned and bottled foods generally have shelf lives up to 3 years and the current Proposition 65 warning regulation applies to products produces post-May 2015. With a 1 year of transition period, there is still significant volume of stock products were manufactured or produced before May 2015 remaining on shelves without warnings.

Currently, there is no regulatory requirement for the Proposition 65 warning to name the chemical or its associated health effect. Some businesses may choose to name BPA in their warning message and provide supplementary information about BPA, while others may just simply say that "the food or beverage product contains a chemical known to the State of California to cause birth defects or other reproductive harm". Such general messages may cause confusion among consumers and do not serve the public's interest.

In light of these concerns, the temporary use of a standard and uniform point-of-sale warning message for BPA would address the problems and avoid public confusion resulting from inconsistent warning messages.

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

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.

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.

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.

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.

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.

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:

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.

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:

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)

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.

The specific safety standards and requirements for hoverboards are listed below:

The newly approved regulation will replace the 2008 regulation on the close of April 17, 2017 and it addresses flammability and safety issues related to children's nightwear. There is a period of one year for transitioning from the 2008 regulation to the 2016 regulation. Therefore, a person may comply with either 2003 or 2014 version of the AS/NZS 1249 standard for the products before April 17, 2017.

Note: the Australian Competition & Consumer Commission (ACCC) has not yet adopted the updated standard. Products marketed in Australia shall continue to comply with the AS/NZS 1249:2003 standard until ACCC issues an update.

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

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

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