REACH regulations, one article teaches you all the truth!
In our daily production, the company is often asked by European customers to test whether the product contains SVHC, whether it meets the requirements of REACH, etc. But where these terms come from, what are the specific requirements, and how to distinguish them, companies are often not particularly clear. In fact, the terms SVHC, REACH Authorized Substances, and REACH Restricted Substances are the requirements put forward by the REACH Regulations specifically to control the use of chemical substances in products.
These requirements can be divided into three types of substances due to the way of control, namely: SVHC (substances of very high concern), authorized substances and restricted substances, corresponding to three lists: SVHC list, REACH Appendix 14, and REACH Appendix 17.
|SVHC (Subtances of Very High Concern)Authorized substanceRestricted substance||SVHC list:REACH Annex 14REACH Annex 17|
Let’s analyze each substance (list) in detail
SVHC is Substance of Very High Concern (substance of very high concern). SVHCs are generally updated in January and July each year, and as of October 2021, there are a total of 219 SVHCs.
According to Article 57 of REACH regulations, there are 6 characteristics in total:
|1||C: Class 1 or Class 2 Carcinogens|
|2||M: Class 1 or Class 2 Mutagen|
|3||R: Category 1 or Category 2 reproductive toxic substances (Reproduction)|
|4||PBT: Persistent, Bioaccumulative, Toxic Substances|
|5||vPvB: Very persistent, very bioaccumulative substances|
|6||Others: Substances that seriously affect human health and the environment (environment hormones, etc.)|
**Substances that meet one or more of the above 6 criteria may be identified as substances of very high concern.
▌REACH regulations control the requirements of SVHC
1. Notification: If the SVHC content in articles produced in the EU or exported to the EU is > 0.1% and at the same time > 1 ton/year, you need to notify ECHA;
2. Notification: If the content of SVHC in articles produced in the EU or exported to the EU is > 0.1%, it is necessary to notify the downstream of the supply chain about the substance.
▌Authorized Substance Definition
Authorized substances refer to those substances that can only be marketed and used after obtaining an official authorization.
▌Scope of authorized substances
Authorized substances are actually selected from the SVHC list, that is, SVHC is a candidate substance for authorized substances. Therefore, the SVHC list has another name: Candidate List.
▌List of authorized substances
Officially announced authorized substances will be included in Annex 14 of REACH.
▌REACH Requirements for Authorized Substances
According to the requirements of the REACH regulation, the use and placing on the market for use of substances listed in Appendix 14, whether it is the substance itself, as a mixture component or used in articles, after a specified date (the regulation refers to this date as the "sunset date") ”(sunset date)), are prohibited unless the use is authorized or falls within an exempt application. Simply put, an authorized substance needs to obtain the relevant authorization from the EU before it can be exported to the EU after its sunset date.
According to the requirements of the regulations, when the sunset date of the authorized substance is reached, ECHA will assess whether the substance has an uncontrollable risk to human health or the environment. If there is, ECHA will propose a restriction control requirement for the substance. At this time, The authorized substance may become a restricted substance. In addition, it should be noted that the placing on the market and use of articles containing authorized substances do not require authorization. That is, the authorization is a requirement for substances, not for articles.
▌Definition of Restricted Substances
Restricted substances are restrictions on the use of certain substances in products.
▌List of Restricted Substances
REACH Annex 17 is the complete list of restricted substances, mainly those substances that pose unacceptable risks to human health or the environment. The current restrictions have been updated to 73 articles, of which article 72 (controlling 33 restricted substances in clothing and related accessories, textiles and footwear products that directly contact the skin) will be officially implemented on November 1, 2020. Article 73 will enter into force after January 2, 2021.
▌Regulatory Requirements for Restricted Substances
The use of restricted substances must comply with the requirements in Annex 17 of REACH.
Article 43 of Appendix 17 requires that banned azo dyes should not be used in textiles and leather that may come into direct or long-term contact with human skin or oral cavity, and the limit is that the content of each aromatic amine should not exceed 30ppm.
Then, clothing companies need to pay close attention to this restriction to ensure that banned azo dyes are not used in textile and leather dyeing products. Other companies, such as toy manufacturers, who use dyed and touchable textile and leather parts in their products also need to pay attention to whether they use banned azo dyes to avoid violations. If the product violates the relevant requirements in the list of restricted substances, the product will be prohibited from being sold on the EU market.
▌The relationship between the three substance lists of REACH
- ECHA evaluates the use and toxicity of CMR, PBT, vPvB, and Others six chemical substances, and confirms whether to add the substance to the SVHC list.
- The substances in the SVHC list will be continuously tracked by ECHA, and after continuous tracking of the feedback information, it will be evaluated whether to add some substances to the authorization list (Appendix 14).
- After the authorized substance (Appendix 14) reaches the specified date, ECHA will assess whether the substance has uncontrollable risks to human health or the environment, and consider whether to add the substance to the restricted list (Appendix 17).
|SVHC list||List of authorized substances||List of Restricted Substances|
|Material properties||CMR1A/1B; PBT; vPvB; Substances with similar hazards, such as endocrine disrupting substances||Same as SVHC||Substances that pose an unacceptable risk to human health or the environment|
|Quantity of substances (as of October 2021)||A total of 219 items||54 items in total||Total 73|
|Relationship to other lists||It is a candidate substance for authorized substances||Authorized substances may be considered for inclusion in the list of restricted substances after sunset||/|
|Chapters in REACH||Article 57||Appendix 14||Appendix 17|
With the continuous update of REACH regulations, enterprises are facing more and more control requirements. Enterprises exporting to Europe should make preparations in advance to effectively prevent subsequent risks. CTT will continue to pay attention to the development of REACH regulations and deliver the latest information to you.The reference materials in this article are from the original text of the REACH regulation.