EU REACH Regulation Undergoes Revision on Lead Restriction

The European Union (EU) is seeking comments for the draft guidance document on the restriction of lead in articles intended for the general public that can be mouthed by children. The deadline for comments will be 11 June 2015.

Comments Awaited on REACH Draft Guidance

On 23 April 2015, the EU published Regulation (EU) 2015/628 to expand the restriction of lead to articles or accessible parts of articles for the general public if such products or components can be placed in the mouth by children under normal or reasonably foreseeable conditions of use.

On 1 April 2015, the European Chemicals Agency (ECHA) announced a call for comments on the draft guidance document in relation to the restriction of lead in articles for the general public or accessible parts thereof that can be placed in the mouth by children during normal and reasonably foreseeable conditions of use in entry 63 under ANNEX XVII of REACH.

Mouthable Articles Targeted

According to the draft guidance, the primary group at risk is children aged between 6 and 36 months. The restriction targets the following 3 conditions:

- Items are supplied to the general public and contain lead or lead compounds in any accessible part of the article at a concentration equal or greater than 0.05%.

- Are likely to be placed in the mouth by small children.

- Are not already covered by any other EU specific legislation regulating lead.

Mouthability of Items Defined

A major factor in determining whether an article is under the scope is ‘if the article can be placed in the mouth by children’. ‘Placing in the mouth’ is defined as ‘the article or parts of the article can be brought to the mouth and kept in the mouth so that it can be sucked and chewed. If the object can only be licked, it is not regarded as ‘placed in the mouth.’

By analogy, and considering 2 important factors for mouthability to all consumer articles, an article supplied to the general public may be included within the scope if:

- It does not exceed 5 cm in all of its 3 dimensions.

- It has accessible parts, detachable or protruding parts with at least 1 dimension less than 5 cm.

- ‘Mouthability’. By definition, inaccessible parts of articles cannot be placed in the mouth.  

Note that:

- Accessibility can be assessed in accordance with EN 71-1.

- Normal and foreseeable conditions of use where an article must be available for children to their mouths under these circumstances.

Assistance on Determination of Mouthability

The draft guidance provides a ‘stepwise approach’ to assess whether an article is within the scope.  It also provides a non-exhaustive list and a decision tree to determine which articles fall in the scope of restriction.  Outdoor items, with some exceptions, are not considered accessible to small children in their immediate environment. It is interesting to note, however, that garden hoses are considered to be mouthable and accessible to children especially when these products are lying on the grass. Town footwear with rubber, plastic or leather outer soles and textile uppers would also be considered within the scope (Annex 4).

The deadline for comments will be June 11, 2015. The guideline is intended to be published on the ECHA website to assist economic operators and enforcement authorities.

The full list of examples of articles that are considered as falling under the scope can be found in Annex-1 of the draft guidance document. Examples of outdoor articles that are considered to be inside or outside the scope of the restriction can be found in ANNEX-4 of the draft guideline.  Highlights of some articles considered as falling under the scope are summarized in a table within the latest SGS Safeguards bulletin (http://newsletter.sgs.com/eNewsletterPro/uploadedimages/000006/sgs-safeguards-07215-eu-comments-draft-guideline-lead-reach-a4-en-15.pdf).

References:

- Regulation (EU) 2015/628, SGS Safeguards bulletin # 069/15 – April 2015 (http://newsletter.sgs.com/eNewsletterPro/uploadedimages/000006/sgs-safeguards-06915-eu-expands-lead-restriction-under-reach-a4-en-15.pdf)

- European Chemicals Agency, ECHA calls for comments and evidence (http://echa.europa.eu/addressing-chemicals-of-concern/restriction/calls-for-comments-and-evidence/-/substance-rev/7902/term)

- ECHA Draft Guidance Document – Draft Guideline on the scope of the upcoming amendment of Entry 63 of Annex XVII to REACH (http://echa.europa.eu/documents/10162/a55e40f4-9515-475a-a6de-25bd991c3f84)

About SGS Chemical Safety of Consumer Products

Throughout its global network of laboratories, SGS is able to provide a range of services, including analytical testing and consultancy, for lead in consumer products under REACH Regulation for the EU (http://www.sgs.com/reach) and international markets.

Please do not hesitate to contact an SGS expert for further information.

Contact details:

SGS Consumer Testing Services

HingWo Tsang
Global Toys and Juvenile Products Information and Innovation Manager
SGS Hong Kong Limited
1/F On Wui Centre
25 Lok Yip Road
Fanling, N.T., Hong Kong, China

t: +852 2774 7420
Email: [email protected]   
Website: www.sgs.com/cgnr

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 80,000 employees, SGS operates a network of over 1,650 offices and laboratories around the world.