April 2016

2016年4月1日，美国环境健康危害评估办公室（OEHHA）发布了一份《紧急行动通知》（Notice of Emergency Action To Amend Section 25603.3 Title 27, California Code of Regulations Warnings for Exposure to Bisphenol A from Canned or Bottled Foods and Beverages），建议对罐装和瓶装食品及饮料暂时使用双酚A（BPA）标准销售点警告信息。拟议的警告信息旨在防止出现不一致的警告信息，减少消费者产生混淆的机会，并保护消费者免受双酚 A 生殖毒性的危害。 双酚 A 于 2015 年 5 月 11 日被列入 65 号提案清单，其警告要求从一年后开始生效（参见《法规回顾：第 2 期，2015 年 5 月》）。与此同时，在另一个规则制定过程中，OEHHA提议针对皮肤暴露制定双酚A最大允许剂量水平（MADL），但不包括从食品和饮料中口服双酚A的暴露。因此，最高允许摄入量不包括金属食品和饮料罐中使用的环氧树脂内衬。使用环氧树脂内衬的产品可能会导致暴露于双酚 A，因此可能需要发出警告。

一旦警告标签要求生效，零售商可能会在所有可能含有双酚 A 的食品和饮料产品上标注警告，而其他零售商可能会有选择性地、不一致地标注警告。这是因为罐装和瓶装食品的保质期一般长达 3 年，而目前的 65 号提案警告规定适用于 2015 年 5 月后生产的产品。虽然有 1 年的过渡期，但仍有大量在 2015 年 5 月之前生产或制造的库存产品仍在货架上，没有警告。

目前，没有法规要求第 65 号提案的警告必须指出化学品的名称或其相关的健康影响。一些企业可能会选择在警告信息中指出双酚 A 的名称，并提供有关双酚 A 的补充信息，而另一些企业则可能只简单地表示 "该食品或饮料产品含有一种加利福尼亚州已知会导致出生缺陷或其他生殖伤害的化学物质"。这种笼统的信息可能会给消费者造成混淆，不利于公众利益。

鉴于这些问题，临时使用标准统一的双酚 A 销售点警告信息可以解决这些问题，并避免因警告信息不一致而引起公众混淆。

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

2016 年 3 月 19 日，一项为期 60 天的临时禁令生效，禁止供应不符合特定安全要求的悬浮滑板（又称自平衡滑板车）。这项禁令影响到任何供应悬浮滑板的人，包括制造商、进口商、分销商和零售商。

悬浮滑板的具体安全标准和要求如下：

2016 年 4 月 18 日，新的《2016 年产品安全标准（具有降低火灾危险性的儿童睡衣和有限日装）法规》正式生效。该法规采用了更新后的标准 AS/NZS 1249：2014《降低火灾危险的儿童睡衣和有限日装》，并将废除此前于 2008 年发布的同名法规（参见法规回顾：2016 年 3 月）。

新批准的法规将于 2017 年 4 月 17 日结束时取代 2008 年法规，该法规涉及与儿童睡衣相关的易燃性和安全性问题。从 2008 年法规到 2016 年法规的过渡期为一年。因此，在 2017 年 4 月 17 日之前，个人的产品可以符合 2003 或 2014 版的 AS/NZS 1249 标准。

注：澳大利亚竞争与消费者委员会 (ACCC) 尚未采用更新后的标准。在澳大利亚销售的产品应继续遵守 AS/NZS 1249:2003 标准，直至 ACCC 发布更新标准。