REACH Regulation

Registration, Evaluation, Authorization and Restrictions of Chemicals

• REACH at a Glance
• Committed to REACH Compliance
• What is REACH?
• Our Company Position
• Use Communication under REACH
• Frequently Asked Questions

REACH at a Glance

• REACH Registration (PDF)
• Substances of Very High Concern (SVHC) (PDF)
• Authorization under REACH (PDF)
• Chemical Safety Assessment (CSA) (PDF)

Committed to REACH compliance

As a family company with a strong commitment to product safety and Responsible Care^®, we endeavor to maintain a cooperative business relationship with all its customers. We are aware of the comprehensive obligations related to the REACH Regulation and we take care of all substances subject to REACH to ensure its own compliance and support our customer to comply with this central chemical regulation.

Our customers can thus rely on us as a competent partner having implemented and still implementing the REACH requirements in various processes, including, but not limited to registration and authorization activities, providing Safety Data Sheets and inform about Substance of Very High Concern (SVHC).

What is REACH?

REACH (Registration, Evaluation, Authorization and Restrictions of Chemicals) is the EU regulatory framework for Chemicals. REACH entered into force on June 1, 2007. The aim of REACH is to enhance protection of human health and environment. This was achieved by passing more responsibility for the management of chemicals to the industry.

REACH establishes European-wide uniform legal standards and has implications for producers, importers, formulators, distributors and users of chemicals, as well as those producing and/or importing articles.

We take this responsibility very seriously and have therefore a proven record in supply chain communication of Substances of Very High Concern (SVHC), doing registrations and authorizations under REACH as well as participating in evaluation projects to keep or bring new products onto the EU market.

We see the implementation of REACH as an opportunity. This is because the faithful collaboration with our customers will be augmented by an additional aspect because REACH requires the exchange of information about the use and Risk Minimization Measures throughout the supply chain, communication will deepen. We want to make this communication so effective that it becomes a business advantage for everyone.

Our company position

As a leading company in life science and technology, we take all necessary actions under REACH in order to continue to expand the supply of our products in Europe. All regulatory requirements concerning REACH are implemented and are part of continuous improvement processes. In order to guarantee compliance at any time, all significant substances regarding REACH are managed by regulatory experts and state of the art IT solutions. We successfully completed all registration deadlines of all substances that are within the scope of the REACH registration requirements and already showed our excellence within the authorization framework under REACH.

Use Communication under REACH

General Information

Under REACH the uses of a chemical substance are an essential part of the registration process. As a major distributor of laboratory and fine chemicals for research, analytical and chemical synthesis as well as pharmaceutical and biotechnological production, we have thoroughly evaluated our own uses and those of our customers. Please note that risk assessments of uses under REACH are only required for products containing substances that are classified as hazardous.

Background Information

The “safe use of chemicals” is a central aim of REACH. The risk assessment of their uses is one tool used to achieve this. This requires the exchange of information between supplier and downstream user. A Chemical Safety Assessment (CSA) is required for all substances subject to registration in volumes of 10 to/a or more. The registrants perform this CSA and document it in the so-called Chemical Safety Report (CSR). The CSR/CSA must be submitted to the ECHA with the dossier as part of the registration and authorization process.
In the CSA all identified uses of a substance are evaluated. Most important tool to evaluate the safe use is the so-called exposure assessment. In this assessment all relevant exposures for human and environment are compared to the potential adverse effects of a substance.

When is use communication not necessary?

In this respect a use communication is not needed for substances which are not classified as dangerous according Regulation EC/1272/2008 (CLP-Regulation). A use communication for substances registered in the tonnage band 1-10 tones per year is also not needed, because no CSA/CSR is required for registration.

What happens if my use is not covered on the eSDS?

We and our suppliers aim to support our customers’ use. Therefore, a great number of exposure scenarios (ES) will be considered for risk assessment. As a result of this effort you will receive a revised and extended Safety Data Sheet (called eSDS) if needed. Only, in this case, you have the obligation to verify whether your use is covered by the described exposure scenarios.

How can I model my own use conditions?

ScIDeEx™ from MilliporeSigma is a free calculation tool which allows customers to find out quickly whether they can use MilliporeSigma chemicals safely within the boundaries of the REACH exposure scenarios. The most important links to the topic.

Frequently Asked Questions

I received a Safety Data Sheet (SDS) without a REACH registration number. Does my product comply with REACH?

The absence of a registration number on a product’s SDS does not indicate the non-compliance of a product:

• Substances manufactured or imported in a tonnage band below 1 t/a and substances exempted from the REACH registration requirement, e. g. substances meeting the requirements of Article 2 of REACH as well as substances listed on Annex IV or V to REACH, will not receive a registration number at all.
• SDS for mixtures only include registration numbers for substances listed in section 3 of the SDS. Non-hazardous substances or substances without occupational exposure level might not be listed therein.
• For registration dossiers submitted close to the registration deadline there is an extended three months period for ECHA to conclude on the completeness of a submitted dossier (Article 20 of REACH). This may also delay availability of a registration number.

Consequently, there will always be a larger number of REACH compliant substances without registration number on the market. Please keep in mind that this situation will not significantly change over the next years.

I am a user of your products for research activities; what are my obligations under REACH?

In general a user of our products in R&D will be considered a "Downstream User" (DU). The main obligations of a DU are to follow the instructions of the Safety Data Sheet especially exposure scenarios that might be attached to the SDS. However, it should be considered, that REACH knows two kinds of research and development, « Scientific Research and Development »(SR&D) and « Product and Process Orientated Research and Development » (PPORD).

In the following you can find a summary of the obligations for substances used in SR&D and PPORD:

I am a non-EU customer. How am I affected by REACH?

As a customer not based in the EU, you are not affected by REACH in most cases. Only export of substances or substances in formulations into the EU in quantities greater than 1 ton per year must be registered by the responsible importer. If you are served from one of our European subsidiaries, all delivered products are REACH compliant, If you are served from a non-EU facility (e.g. UK, Switzerland, North America, South America or Asia), the delivered products are not subjected to REACH and cannot regarded as registered. If you purchase and export chemicals (e.g. as part of a formulation or an article) to the EU in larger volumes we advise you to consult with your appropriate regulatory expert or counsel to determine your or your EU based customers REACH obligations!

Are the products delivered free of SVHC-substances?

One of the targets of REACH is to remove substances, which are extremely hazardous or dangerous for human health and/or the environment, from consumer and industrial products. Therefore, the listing of 'candidates' fulfilling the criteria given in Art. 57 of the REACH Regulation was first published in 2008 by ECHA. This list is called the Candidate List of Substances of Very High Concern (SVHC) and will be updated regularly.

The current candidate list can be found on the ECHA homepage.

Publication of this list imposed duties on industry. The main duties are:

• According to Art. 33 any supplier of an 'article' containing a candidate substance in a concentration above 0.1% w/w must provide information to allow safe use to his end users. On request he must provide this information within 45 days to end users.
• Suppliers of chemical substances and mixtures containing SVHC in a concentration above 0.1% w/w must provide their customers with a safety data sheet (SDS).

As part of our good business practice an SDS is supplied for each product, even if there is no legal obligation.
For all chemical substances and mixtures you will find relevant information on our SDS.

Generally we can say that, to the best of our knowledge and from the information given by our suppliers, our chemical substances and mixtures do not contain any SVHC above the legal limit of 0.1% w/w unless they are SVHCs themselves as indicated on the safety data sheet (SDS).

The inclusion of a substance in the candidate list is the first step to authorization. After the evaluation process a candidate list substance might be added to Annex XIV of the REACH regulation. After the inclusion of a substance into Annex XIV a special authorization is needed for further use.