HQTS Quality Control

REACH Testing

REACH Testing

Regulation (EC) No. 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals entered into force on 1 June, 2007. Its aim is to strengthen the management of the production and use of chemicals for increasing the protection of human health and environment.

REACH applies to substances, mixtures and articles, impacts most products placed on EU market. The exemption products of REACH are defined by the Act of each Member States, such as defence, medical, veterinary medicines and foodstuffs.

There are 73 Entrys in REACH ANNEX ⅩⅦ, but  the 33rd Entry, the 39th Entry and the 53rd Entry were deleted during the revision process, so there are only 70 Entrys accurately.

High Risk and High Concern Substances in REACH ANNEX ⅩⅦ

High Risk Material RS Entry Testing item Limitation
Plastic,  coating, metal 23 Cadmium 100mg/kg
Plasticised material in Toy and child care products 51 Phthalate (DBP, BBP, DEHP, DIBP) Sum<0.1%
52 Phthalate (DNOP, DINP, DIDP) Sum<0.1%
Textile, leather 43 AZO Dyes 30 mg/kg
Article or part 63 Lead and its compounds 500mg/kg or 0.05 μg/cm2/h
Leather, textile 61 DMF 0.1 mg/kg
Metal(contact with skin) 27 Nickel Release 0.5ug/cm2/week
Plastic,rubber 50 PAHs 1mg/kg (article); 0.5mg/kg(toy)
Textile, plastic 20 Organic tin 0.1%
Textile, leather 22 PCP (Pentachlorophenol) 0.1%
Textile, plastic 46 NP (Nonyl Phenol) 0.1%

EU has published Regulation (EU) 2018/2005 on 18 Dec. 2018, the new regulation gave the new restriction of phthalates in the 51st entry, it will be restricted from 7 July 2020. The new regulation has been added a new phthalate DIBP, and it extends the scope from toy and child care products to aircraft produced. That will impact a lot to the Chinese manufacturers.

Based on the evaluation of chemicals, European Chemicals Agency (ECHA) included some high-risk chemicals into SVHC (Substances of Very High Concern). The first 15 SVHC list was published on 28 Oct. 2008. And with the new SVHCs added continuously, currently total 209 SVHCs have been published until 25 June 2018. According to the ECHA schedule, a “Candidate List” of additional substances for possible future inclusion in the list will be published continuously. If the concentration of this SVHC is >0.1% by weight in the product, then the obligation of communication applies to the suppliers along the supply chain. In addition, for these articles, if the total quantity of this SVHC is manufactured or imported in the EU at >1 tone/year, then notification obligation applies.

The new 4 SVHCs of the 23rd SVHC list

Substance name EC No. CAS No. Date of inclusion Reason for inclusion
Dibutylbis(pentane-2, 4-dionato-O,O’) tin 245-152-0 22673-19-4 25/06/2020 Toxic for reproduction(Article 57c)
Butyl 4-hydroxybenzoate 202-318-7 94-26-8 25/06/2020 Endocrine disrupting properties (Article 57(f) – human health)
2-methylimidazole 211-765-7 693-98-1 25/06/2020 Toxic for reproduction(Article 57c)
1-vinylimidazole 214-012-0 1072-63-5 25/06/2020 Toxic for reproduction(Article 57c)
Perfluorobutane sulfonic acid (PFBS) and its salts 16/01/2020 -Equivalent level of concern having probable serious effects to human health (Article 57(f) – human health)

– Equivalent level of concern having probable serious effects to human environment (Article 57(f) – environment)

OUR SERVICES:

  • Consultant about chemical substance REGISTER
  • SVHCs screening test of REACH ANNEX XVII Restriction substance list
  • Process audit
  • Technique support for MSDS/SDS
  • To assist you, HQTS will put a series of REACH awareness training programs.

PRODUCTS COVERED BY REACH:

  • Chemicals
  • Electrical & Electronic products, motors
  • Textiles, shoes, leather, accessories

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