PAHs in Europe

On 6 December 2013, Commission Regulation (EU) No 1272/2013 was published on the Official Journal which extended the restriction of polycyclic aromatic hydrocarbon (PAHs) to rubber or plastic components in articles that come into direct and prolonged or short-term repetitive contact with human skin or the oral cavity, under normal or reasonably foreseeable conditions of use. This regulation has also amended the REACH regulation by adding the PAHs requirements under entry 50 of Annex XVII of REACH. The new requirements shall be effective from 27 December 2015. This requirement is summarized as below:

PAHs, CAS No.	Restricted in rubber or plastic components in articles with prolonged skin contact	Requirement (each PAH)
. Benzo[a]pyrene (BaP), 50-32-8 . Benzo[e]pyrene (BeP), 192-97-2 . Benzo[a]anthracene (BaA), 56-55-3 . Chrysen (CHR), 218-01-9 . Benzo[b]flouranthene (BbFA), 205-99-2 . Benzo[j]flouranthene (BjFA), 205-82-3 . Benzo[k]flouranthene (BkFA), 207-08-9 . Dibenzo[a,h]anthrcene (DBAhA), 53-70-3	Ø    Toys including activity toys and childcare articles	£ 0.5 mg/ kg
	Ø    Sport equipment such as bicycles, golf clubs, racquets Ø    House-hold utensils, trolleys, walking frames Ø    Tools for domestic use Ø    Clothing, footwear, gloves and sportswear Ø    Watch-straps, wrist-bands, masks, head-bands	£ 1 mg/ kg

These PAHs are present as impurities in some of the raw materials used in the production of plastic and rubber parts of a wide range of consumer products, in particular in extender oils and in carbon black. They are not added intentionally to the articles and do not perform any specific function. These PAHs are banned for sale as substances on their own or in mixtures to the general public by entry 28 of Annex XVII to REACH. Entry 50 of Annex XVII to REACH already restricted the presence of PAHs in extender oils used for the production of tyres.

Effective Date:	27 December 2015
Scope:	Rubber or plastic with prolonged skin contact
Hazard:	PAHs
Limit:	Refer to above details
Risk:	https://en.wikipedia.org/wiki/Polycyclic_aromatic_hydrocarbon

Total Lead Content in Europe REACH

In additional to Jewelry and its' component, the articles or accessible parts which may be placed in the
mouth by children should not have lead content more than 0.05%

Safety / Risk Assessment

 The safety/ risk assessment is a hot topic at the beginning of 2009/48/EC,  that mentioned in Article 18 “ Manufacturers shall, before placing a toy on the market, carry out an analysis of the chemical, physical, mechanical, electrical, flammability and radioactivity hazard that the toy may present, as well as an assessment of the potential exposure to such hazards.”

EN71 is harmonized standard for assessment of physical, mechanical, flammability and some chemical hazards.

The assessment can be conducted by manufacturer or labs. There is no accreditation requirement and any format for assessment report in the 2009/48/EC. Assessment records cover all hazards area is okay, it may not assess according to EN71 standards.

Europe EN71 Part 3 proposed update on lead limit

The European Commission is proposing to amend the lead limit in Annex II of Directive 2009/48/EC: 

	In dry brittle, powder like or pliable toy material (mg/kg)	In liquid or sticky toy material (mg/kg)	In scraped –off toy material (mg/kg)
Current Lead limits	13.5	3.4	160
Proposed Lead limits	2.0	0.5	23

Formamide Regulation in France and Taiwan

For Europe:

The formamide is proposing to be added in 2009/48/EC with limit for toys (playmat is included) as below 

Refer: http://ec.europa.eu/enterprise/tbt/tbt_repository/EU231_EN_1_1.pdf

While above propose is not effective yet, the Europe regulation for consumer product should be as below:

The marketing of puzzle mats containing formamide was restricted in some member States. Can formamide be used in toys?

Formamide is a CMR classified as reprotoxic cat 2 (or 1 B according to 1272/2008).

According to the current Toy safety directive 88/378/EEC, toys shall not contain dangerous substances in amounts which may harm the safety and health of children.
It is the responsibility of the manufacturer to demonstrate that toys they place on the EU market comply with this requirement. National market surveillance authorities have the obligation to verify and take measures the case may be.

The new Toy Safety Directive 2009/48 introduces, as from July 2013, a general ban on CMRs substances. As an exception, they can be used when they are contained in concentrations equal or below the concentrations mentioned in Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures (0.5% for formamide).

Refer: http://ec.europa.eu/DocsRoom/documents/5572/attachments/1/translations/en/renditions/native

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For France, the national regulation for puzzle playmat is as

Limit: <200 mg/kg

Refer: http://www.legifrance.gouv.fr/affichTexte.do;jsessionid=?cidTexte=JORFTEXT000026258509&dateTexte=&oldAction=rechJO&categorieLien=id

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For Taiwan, the national regulation for Toys and playmat are:

Limit: <2mg/kg (which is same as the withdrawed limit of France on 1 August 2012)

Refer: http://www.cnsonline.com.tw/?node=result&generalno=15493&locale=zh_TW

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The taiwan requirement was commented by European commission as below:

https://members.wto.org/crnattachments/2014/tbt/CHT/14_2983_00_e.pdf

http://ec.europa.eu/enterprise/tbt/tbt_repository/TPKM165_EN_1.pdf

EN71 Part 12 Safety of toys - Part 12: N-Nitrosamines and N-nitrosatable substances

Regulated Chemical:
Nitrosamines and Nitrosatable Substances
Counties:
Europe
Effective Date:
20 July 2013
Scope:
Elastomers in toys and parts of toys intended for use by children under 36 months (e.g. teethers)

Elastomers in toys and parts of toys intended to be placed in the mouth (e.g. balloons)

Finger paints

Limit:

 Tab1. The limits of  N-nitrosamines and N-nitrosatable substances(mg/kg)

Substances	Scope
	elastomeric toys and parts of toys intended for use by children under 36 months	elastomeric toys and parts of toys intended to be placed in the mouth(e.g. balloons and teethers)	finger paints intended for use by children under 36 months
N-nitrosamines	0.05		0.02
N-nitrosatable substances	1.0		1.0

Chromium VI in Leather REACH Annex XVII

Chromium based tanning is still an important technical process to convert animal raw hide to leather. Even if chromium VI salts and acids may not be involved in the tanning process nowadays, it is a common phenomenon that chromium III compounds undergo chemical conversion in the tanned leather.

From 1 May 2015, Chromium VI (REACH Annex XVII, Entry 47) should be less than 3 mg/kg in

• Leather articles coming into contact with skin
• Articles containing leather parts coming into contact with the skin

Children Stationery Safety

The product poses a chemical risk due to the release of nickel (up to 30 µg/cm2/week) from its metallic parts ("nib" and "spacer bar") exceeding the limit value of 0.5 µg/cm2/week. The product does not comply with the REACH Regulation.

RoHS is now 2011/65/EU directive from 2002/95/EC

EN71-1:2011+A2:2013

Per 4.28 Acoustic requirements See Clause E.41. When tested in accordance with 5.25 (determination of sound pressure levels), toys that are designed to emit sound shall conform to the following requirements. a) b) The A-weighted equivalent sound pressure level, LpAeq, of continuous sounds produced by close-to-theear toys shall not exceed 65 dB. The A-weighted equivalent sound pressure level, LpAeq (maximum A-weighted sound pressure level, LpAmax, for pass-by tests), of continuous sounds produced by all other toys except close-to-the-ear toys shall not exceed 85 dB. The C-weighted peak sound pressure level, LpCpeak, of impulsive sounds produced by close-to-the-ear toys shall not exceed 95 dB. The C-weighted peak sound pressure level, LpCpeak, of impulsive sounds produced by any type of toy excluding toys using explosive action (e.g. percussion caps) shall not exceed 115 dB. The C-weighted peak sound pressure level, LpCpeak, of impulsive sounds produced by a toy using percussion caps or other explosive action shall not exceed 125 dB. If the C-weighted peak sound pressure level, LpCpeak, of impulsive sounds produced by a toy using percussion caps or other explosive action exceeds 115 dB, the potential danger to hearing shall be drawn to the attention of the user (see B.2.19). c) d) e) f) The requirements in this subclause do not apply to: mouth-actuated toys, i.e toys the noise level of which is determined by the blowing action of a child (e.g. whistles and imitation musical instruments, such as trumpets and flutes); child-actuated toys, i.e. toys the noise level of which is determined by the muscular action of the child (e.g. xylophones, bells, drums, squeeze toys). The continuous sound pressure requirements do not apply to rattles; however, rattles are covered by impulsive sound pressure requirements; radios, tape players, CD players and other similar electronic toys; toys that are connected to or interfaced with external devices (e.g. televisions, computers) where the sound pressure level is determined by the external device; sound emitted from earphones/headphones. En71:2013+A2 definition: rattle : toy, intended for children who are too young to sit up unaided, that is clearly designed to emit sound when shaken or activated by the child or another person percussion toy: toy clearly designed to emit sound when struck with a beater, such as a drumstick, or by the hand NOTE Examples of percussion toys include drums, xylophones and tambourines

EN71 Part 1:2013+A2

Europe Book vs Toy classification

http://ec.europa.eu/enterprise/sectors/toys/files/guidance-documents/guidance-document-9-books_en.pdf

REACH SVHC Article definition

Current ECHA guidance regarding calculation of the 0.1% threshold would regard only a selling unit as a complete article. So the complete article approach is currently not only that of ECHA but also that of most other EU-Nations.

A simple illustration of both principles of belt containing a buckle and a strap is shown below:

According to the “once an article always an article approach,” before the belt was manufactured, the strap was an article and the buckle was an article. Therefore if the SVHC was present above 0.1% in the strap, the SVHC obligations would apply irrespective of the weight of the buckle. If the current ECHA guideline is followed, the weight of the buckle is changing the weight distribution so that the SVHC share of the Article “Belt” stays below 0.1% and the obligation for information does not apply.

Irrespective to the approach for calculating SVHC content the guidance document, issued by the six dissenting nations, contains useful information and supplies worked examples of how to calculate the overall weight of chemicals present for a whole range of consumer items from printed T – Shirts; Electrical Cables; Desktop Computers, Kitchenware etc.

Bureau Veritas will inform clients of developments in this area since in the longer term the current situation has to be resolved by the members of the European Union.

http://www.kemi.se/Documents/Forfattningar/Reach/Guidance_for_suppliers_of_articles_EN.pdf

Nickel Release recall in Europe

17 A12/1957/13

Croatia

Category: Toys Product: Key chain Brand: Unknown Name: Llavero cubo magico (magic cube keychain) Type/number of model: 1101831 Batch number/Barcode: 8433774500025 OECD Portal Category: 86000000 - Toys / Games Description: Product is a key chain which consists of cube with sides of different colors (Rubik's cube style) packed in blister packaking. Packaging contains inscriptions LLAVERO, CUBO MAGICO. Country of origin: China

Chemical The product poses a chemical risk because the metal ring releases an excessive amount of nickel (0.83 µg/cm2/week). The product does not comply with the REACH Regulation.

Compulsory measures: Ban on the marketing of the product and any accompanying measures, Withdrawal of the product from the market, Destruction of the product

EN1078, EN1080 bicycle requirement

Answer given by Mr Tajani on behalf of the Commission
Bicycles helmets are subject to the provisions of Directive 89/686/EEC on personal protective equipment (PPE Directive)(1). This directive is a so-called New Approach Directive which means that harmonisation is limited to essential health and safety requirements while technical specifications are set out in harmonised standards developed by the European Committee for Standardisation (CEN). In particular, EN 1078:1997 Helmets for pedal cyclists and for users of skateboards and roller skates and EN 1080:1997 Impact protection helmets for young children provide presumption of conformity under the PPE Directive.

In 2005, the Commission carried out an inquiry involving Member States and CEN in order to explore how children could be better protected.

In the course of 2005, CEN adopted two amendments to the above referred to standards adding additional elements for the marking requirements:

— EN 1080:1997/A2:2005 Part 6 Marking, point h, reads: ‘Warning! This helmet is fitted with self-release retention system designed to release under certain loading conditions in order to avoid possible strangulation/hanging. It may come off in a severe crash.’
— EN 1078:1997/A1:2005 Part 6 Marking, point h, reads: ‘Warning! This helmet should not be used by children while climbing or doing other activities when there is a risk of strangulation/hanging if the child gets trapped with the helmet.’
Further it could be concluded from the information the Commission received that the safety characteristics of the helmets are appropriate in their respected field of application but problems may occur in case of inappropriate selection of the helmets for their use.

This is mainly due to the following reasons:

Helmets designed according to standard EN 1078 are suitable for bicycle riding as the standard provides for a chain strap that is not designed to release above a certain force. In other words the helmet stays in place in case of a severe crash in order to protect the skull.

Standard EN 1080 was originally designed for helmets to be used at playgrounds and it provides for a chin strap that releases above a certain force in order to prevent serious injury or fatal accidents due to strangulation. In other words the helmet is designed to disengage from the head.

Therefore, the Commission wrote to the Member States and the Chairman of the Notified Bodies in order to draw their attention to the fact that it was standard EN 1080:1997 that had to be applied if presumption of conformity was required under the PPE Directive for helmets for children where there was a risk of strangulation.

Since then, the Commission has not become aware of any fatal accidents in the field. Nevertheless the Commission will discuss this topic again with PPE stakeholders including CEN in order to see the magnitude of the issue that the Honourable Member raised.

As regards key lanyards, the Commission has published on its website information on the strangulation hazards posed by clothing strings, loose items and other hanging items in the playground(2). According to this information, parents are advised to remove clothes with cords or strings, necklaces, long earrings and loose items in pockets before the child enters in the playground.

Furthermore, in 2008 the Commission co-financed a joint market surveillance action to assess the safety of playground equipments in seven Member States and raise awareness of parents, landscape designers, municipalities and schools to ensure that children can play safely in playgrounds.


(1) Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment, OJ L 399, 30.12.1989.
(2) http://ec.europa.eu/consumers/reports/rights_child_safety_prod.pdf.. See also
http://europa.eu/rapid/pressReleasesAction.do?reference=MEMO/10/98&format=HTML&aged=0&language=EN&guiLanguage=en
http://www.eurosafe.eu.com/csi/eurosafe2006.nsf/0/ABAD24D81CFF6937C125718500337AFB/USD file/Playground%20equipment.pdf

http://www.europarl.europa.eu/sides/getAllAnswers.do?reference=P-2010-3179&language=EN

REACH SVHC 151 updated

http://echa.europa.eu/web/guest/candidate-list-table

REACH Annex XVII PAHs Scope updated

From 27 December 2015, plastic and rubber parts shall not contain PAHs with more than:

• 1 mg/kg in articles in direct and prolonged or short-term repetitive contact with the skin or oral cavity. This includes sport equipment, tools, clothing, apparel etc.

• 0.5 mg/kg in toys in direct and prolonged or short-term repetitive contact with the skin or oral cavity.

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:328:0069:0071:EN:PDF

Azodye requirement in Plush toy

http://www.bristol247.com/2013/10/02/baby-toy-recalled-bristol-stores-cancer-scare-91878/

2012 Europe Recall review

http://ec.europa.eu/consumers/docs/rapex_infograph_2012_en.pdf

Toy Safety