8 July 2016
Q&As Revisited for Several Commonly Sold Consumer Goods Including Toys, and How the REACH Restrictions Apply to Them
Hong Kong traders may recall past encounters with the REACH Regulation, the EU’s complex body of chemicals law. Annex XVII of REACH restricts the placing on the market of substances, either on their own, within mixtures or as part of manufactured articles to be sold to EU consumers.
The European Chemicals Agency (ECHA) periodically publishes guidance documents, including Q&As, to aid businesses in navigating substance restrictions. Below are seven examples of relatively common articles, and constraints, concerning substances that are restricted under REACH. These articles, commonly exported from Hong Kong, may be of interest to Hong Kong traders who deal with the EU.
Toys: A number of Annex XVII entries refer specifically to toys, including Entries 5, 31, 43, 50, 51 and 52. However, the REACH Regulation does not define “toys”, instead it looks to the definition found in Directive 2009/48/EC, the Toy Safety Directive (the TSD). The TSD defines toys as “products designed or intended, whether or not exclusively, for use in play by children under 14 years of age”. The TSD defines certain types of toys, and additionally provides detailed lists of products not considered to be toys.
The tolerated concentration threshold of phthalates of plasticised material in toys and childcare products is set by Entry 51 of Annex XVII. The intent of the 0.1% limit on phthalates was to eliminate their use. As such, the limit has to be calculated in each piece of plasticised material of each homogenous material. To serve as illustration, if only the head of a doll contains 0.1% of phthalates the calculation is based on the weight of the plasticised material of the head of the doll and not the entire weight of all plasticised material in the whole doll.
The TSD does not apply to the following toys: (a) playground equipment intended for public use; (b) automatic playing machines, whether coin operated or not, intended for public use; (c) toy vehicles equipped with combustion engines; (d) toy steam engines; and (e) slings and catapults. It is considered that if the TSD definition of “toys” is used in Annex XVII of REACH, these exemptions will automatically form part of that definition.
In order to determine what satisfies Entry 52 of Annex XVII’s concept of toys “which can be placed in the mouth,” manufacturers should look towards “size dimension” and “accessible parts” criteria from the EN 71 European Standard on the safety of toys. These guidelines should facilitate judgement on a case-by-case basis whether a toy can be placed in the mouth by children. The guide also provides pictures to better illustrate which toys or parts of toys can be taken into the mouth. The guideline on items which can be “placed in the mouth” by children also covers accessible parts of articles. Thus, car seats and sleeping bags, which facilitate relaxation and sleep, would be covered under Entry 52 of Annex XVII.
Childcare articles: Childcare articles mean products intended to “facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children.” Thus, hygiene articles like bath mats, hairbrushes, bath thermometers and nail cutters are covered and should conform to regulations, such as restrictions on phthalates as found in Entries 51 and 52.
As for articles regarding sleep, Hong Kong traders should look to the “main purpose” of the article. According to REACH guidance, the main purpose of pyjamas is to dress children when sleeping and not to facilitate sleep. Pyjamas are therefore regarded as textiles. On the other hand, mattress protectors are considered childcare articles under REACH. However, because they are not able to be placed into the mouth of children, they do not fall within the restrictions listed in Entry 52.
Blankets are, in nature, articles similar to mattresses. Both are used in bed to facilitate the sleeping of children. Furthermore, since blankets can commonly be placed in the mouth by children, they can be considered within the scope of Entries 51 and 52.
Child seats, push chairs, car seats, sleeping bags and bike seats are intended to facilitate sleep and relaxation during transport. These can broadly be considered as childcare articles.
In contrast, a baby monitor falls outside the scope of Entries 51 and 52 of Annex XVII. A baby monitor is a product that allows parents to be alerted when the baby is crying or making other noise. A baby monitor is not a product intended “to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children.”
Metal parts of jewellery: Annex XVII to REACH states that cadmium shall not be used or placed on the market if the concentration is equal to or greater than 0.01% of the metal in metal parts of jewellery.
This concentration threshold of cadmium applies in each metal part of the jewellery. For example, if there are several metal layers as coating on the surface of an inner (metallic) part of the jewellery, these layers should be regarded as an integral part of the inner metal part and the concentration limit of 0.01% is calculated for the whole. In cases where the inner part is not metal, but the coating is made of metal layers, this coating is regarded as one metal part. If the jewellery article contains several metal parts, then each of them should comply with the concentration limit.
Nickel and skin contact: Nickel should not be used “in articles intended to come into direct and prolonged contact with the skin, if the rate of nickel release from the parts of these articles coming into direct and prolonged contact with the skin is greater than 0.5Jg/cm2 /week.”
“Prolonged contact” is defined as contact with the skin to articles containing nickel for potentially more than 10 minutes on three or more occasions within two weeks, or 30 minutes on one or more occasions within two weeks. The restriction protects consumers against a nickel allergy caused by prolonged direct contact of the skin with nickel-releasing articles, including jewellery, buttons, zips and rivets in items of clothing.
Mobile telephones provide an illustration; some mobile telephones contain nickel in surface material. As mobile telephones are clearly intended to come into direct contact with the skin, and as they are used on a daily basis often for prolonged periods of time, mobile telephones fulfil the condition of “direct and prolonged contact with the skin.” Therefore, mobile telephones are covered by the restriction and should comply with the conditions set in Entry 27 of Annex XVII of REACH.
Cosmetic products: REACH does not specifically define cosmetic products. According to Regulation 1223/2009 on cosmetic products, “cosmetic product” means: “any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.”
There is a ban on the marketing of cosmetic products containing nonylphenol (CAS: 25154-52-3) and 4-nonylphenol, branched (CAS: 84852-15-3). The presence of traces in cosmetic products is allowed, provided that such presence is unavoidable in good manufacturing practice and that the product does not cause damage to human health.
In complement to the above, another provision of REACH bans the placing on the market of nonylphenol and nonylphenol ethoxylates in mixtures, including cosmetics, when the concentration is higher than 0.1% by weight.
Personal care products: Cosmetics are considered as a subcategory of personal care products in REACH, specifically in Entry 46. The restrictions’ application includes products used for personal hygiene, such as toilet paper, some female hygiene products, nappies, cotton pads, etc.
Decorative oil lamps: Within the context of Entry 3 of Annex XVII, an indicative description of “decorative oil lamps” is provided by the European Standard EN 14059 (section 3.6): “Oil lamp for decorative purposes is an oil lamp for interior or exterior use (e.g. in garden torches) appealing by its design and/or the light atmosphere it creates.”
For more details and other restriction guidelines, please see the ECHA Q&As webpages, where searches may be conducted on Q&As.