REACH

• Pre-registration of phase-in substances (few exceptions possible after 1.Dec. 2008)
• Registration
• Restriction
• Authorisation
• Communication and information transfers in the supply chain

What are SVHC?
SVHC stands for substances of very high concern for human health or the environment, which meet the following characteristics:

• Carcinogenic, mutagenetic, or reprotoxic (CMR) category 1 or 2 according to Directive 67/548/EEC;
• Persistent, bioaccumulative and toxic (PBT) or very persistent, and very bioaccumulative (vPvB) according to the criteria of Annex VIII of the REACH regulation and/or;
• Substances giving rise to an equivalent level of concern to substances meeting the above criteria. Such substances may have endocrine disrupting properties or have properties, that although not meeting the criteria for being a CMT, PBT or vPvB, there is scientific evidence of probable serious effects to human health or the environment. Such substances will be identified on a case-by-case basis.

The competent EU member state authorities hold consultations several times a year to agree on which potential SVHC should be added to the ECHA SVHC Candidate List. Substances on this list are possible candidates for the procedure of authorisation.

SVHC may be used intentionally, for example as softeners, fire-retardents or in other functions as additives. However, they may also end up unintentionally in consumer products through use of recycling compounds, based on complex manufacturing processes, or within the supply chain.

Which requirements for SVHC exist in the supply chain?
With each extension of the candidate list, the responsibility grows for each company dealing with articles or preparations, manufacturing or importing such products, to have knowledge of potential constituents bearing risks for human health or the environment. According to Art. 33 of the REACH regulation, each supplier of articles and preparations in the EU is required to provide his commercial clients information on whether any of the substances listed on the SVHC Candidate List are present in the product in a in a concentration of > 0.1% (w/w). This information is meant to allow safe use of the product. At a minimum the name of the SVHC exceeding the threshold concentration needs to be given to the client automatically and free of charge with delivery of the product.

In the long-run, this will lead to a multitude of requests for information along the supply chain. In addition, the pressure to comply is heightened by non-governmental organisations (NGOs).

Requirements towards the consumer
On request of a consumer, the supplier has to provide information on any substance exceeding the threshold concentration within 45 days of the receipt of the request and free of charge.

Requirements towards ECHA
Apart from the information requirements within the supply chain, the additional requirement exists since June 2011 for EU manufacturers and importers to submit a notification to the EU Chemicals Agency (ECHA) for substances of very high concern (SVHC) in their articles and/or preparations, if these are present in their product in a concentration of greater than 0,1% (w/w) (or 0,2%vol for gaseous products), as well as in a volume of greater than 1 ton per calendar year per SVHC in their entire product portfolio. For substances included on the candidate list at a later date than 1. June 2011, notification must be submitted no later than 6 months after the inclusion.

• Production of a substance above 1 ton per calendar year
• Import of substances or preparations from the non-EU countries above 1 ton per calendar year
• Import or production of an article, which under normal or predictable conditions releases a substance in volumes above 1 ton per calendar year

The deadlines for the registration of phase-in substances stretch over a time frame of 11 years from the date that REACH came into force, if your company has pre-registered its phase-in substances.

1. Ensure that your intended use is allowed for by the registration
2. Check the safety data sheet from the supplier for your intended use and communicate all non-compliances to the supplier
3. Implement risk management measures
4. Keep the received information for a minimum of 10 years

Substance Restrictions
The restrictions and bans for dangerous substances for specific uses, which listed in Annex XVII of the EU chemicals legislation REACH, must be met in order for being allowed to market the product in the EU. The regulations previously covered in EC Directive 76/769/EEC were integrated into the REACH reulgation and are amended on a case-by-case basis.

Material Safety Data Sheets
Material safety data sheets for substances and preparations marketed in the EU have to be in conformity with the REACH regulatory requirements.

SGS INSTITUT FRESENIUS has experts, the required accredited laboratories and the needed know-how to support you in a professional manner in complying with your REACH obligations.

We have long-term experience with test methods for testing chemicals on their biodegradability, ecotoxicological properties and environmental fate and are active in the area of alternative in-vitro methods. SGS Institut Fresenius has conducted GLP studies for the registration of chemicals, biocides, fertilizers, and herbicides since 1992. Furthermore SGS can assist you e.g. with the characterization of your substances or the screening of articles concerning substances requiring authorization.

The REACH implementation within each company is a great challenge. Working with SGS, you will have access to a regulatory partner actively involved in REACH, offering products and services supported by knowledge and expertise to ensure compliance. Ensure to meet the deadlines, especially with regards to the Chemical Safety Report by contracting SGS now as your support partner.

Substance Identification according to the REACH Regulation (PDF)