REACH

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 Testing

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 MaterialRS EntryTesting itemLimitation
Plastic,  coating, metal23Cadmium100mg/kg
Plasticised material in Toy and child care products51Phthalate (DBP, BBP, DEHP, DIBP)Sum<0.1%
52Phthalate (DNOP, DINP, DIDP)Sum<0.1%
Textile, leather43AZO Dyes30 mg/kg
Article or part63Lead and its compounds500mg/kg or 0.05 μg/cm2/h
Leather, textile61DMF0.1 mg/kg
Metal(contact with skin)27Nickel Release0.5ug/cm2/week
Plastic,rubber50PAHs1mg/kg (article); 0.5mg/kg(toy)
Textile, plastic20Organic tin0.1%
Textile, leather22PCP (Pentachlorophenol)0.1%
Textile, plastic46NP (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 nameEC No.CAS No.Date of inclusionReason for inclusion
Dibutylbis(pentane-2, 4-dionato-O,O’) tin245-152-022673-19-425/06/2020Toxic for reproduction(Article 57c)
Butyl 4-hydroxybenzoate202-318-794-26-825/06/2020Endocrine disrupting properties (Article 57(f) – human health)
2-methylimidazole211-765-7693-98-125/06/2020Toxic for reproduction(Article 57c)
1-vinylimidazole214-012-01072-63-525/06/2020Toxic for reproduction(Article 57c)
Perfluorobutane sulfonic acid (PFBS) and its salts16/01/2020-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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