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 defense, 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) |
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