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Registration, Evaluation, Authorization and Restrictions of Chemicals
Statement from Steve Walton
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"Sigma-Aldrich has followed the debates and progress of REACH from the early stages so we now have seven years of knowledge to ensure successful REACH implementation. We support the objectives of REACH that comply with our Safety, Health and Environmental Sustainability Policy."
Steve Walton
Vice President
EHS, Regulatory Compliance & Sustainability Services |
The new EU regulatory framework for Chemicals: REACH (Registration, Evaluation, Authorization and Restrictions of Chemicals) entered into force on June 1, 2007. The aim of REACH is to enhance protection of human health and environment. This will be achieved by passing more responsibility for the management of chemicals to the industry.
REACH establishes European-wide uniform legal standards. It replaces the former evaluation of existing substances and the notification of new chemical substances. It has implications for producers, importers, formulators, distributors and users of chemicals, as well as those producing and/or importing articles.
Manufacturers and importers of a substance in quantities below 1 tonne (1000kg) per year are not subjected to registration.
Several groups of substances are either outside the scope or exempted from certain aspects of REACH:
- Pharmaceutical products for human or veterinary use
- Food or feeding stuff additives
- Animal nutrition
- Substances listed in Annex IV (like Glucose, Water, etc.)
- Substances fulfilling the criteria of Annex V (several natural substances, unintended reaction products, etc.)
- Non-isolated intermediates
- Polymers
A complete list of all exempted substances can be found in Article 2 of the REACH regulation.
REACH-Exemptions (PDF, 124 KB)
Please consult the attached REACH decision tree (PDF, 24 KB) to see if you are affected by REACH.
| Phase-In period for existing substances |
The Phase-in period allows smooth implementation and prioritization for registration of substances already on the market (EINECS, NLP). Phase-in is not possible for new chemical substances. They require full registration prior to production or importation should the 1t/y limit be exceeded, before placing them on the market.
As a leading company in Life Science and High Technology we will take all necessary actions under REACH in order to continue to expand the supply of our products in Europe. Sigma-Aldrich completed the pre-registration of all substances that are within the scope of REACH and we are working towards full registration of these substances. At this time we do not plan to discontinue any products because of REACH.
Should you need more information about REACH and our strategy, please contact us. Our REACH team will answer your questions to the best of our knowledge in a timely and efficient manner.
If you use our substances as raw materials in development or production, please contact our
SAFC division for REACH support:
| Sigma-Aldrich is best prepared for REACH! |
- We are familiar with all details of the regulatory framework of REACH
- A REACH implementation team with experts from around the globe is working on the task
- We are collaborating with the Chemical Industry Associations on guidance for a smooth REACH implementation
- We have pre-registered all substances, which are within the scope of REACH
- We will continue to supply our wide range of products in Europe
| Frequently Asked Questions |
Does Sigma-Aldrich guarantee that the products I use will be available in the future / after the pre-registration period has ended?
We have the REACH regulation knowledge and supply chain tools in place in order to continue supplying our wide range of products in Europe. At this time we do not plan to discontinue any products because of REACH.
If a substance is not pre-registered, will it be available in the future?
Manufacturing or importing a substance in quantities above 1 tonne (1000 kg) per year is prohibited if the substance has not been registered or pre-registered, if qualified, after December 2008. However this does not imply that every chemical substance has to be pre-registered! There are specific substances and groups of substances (comp. Annex IV & V) which are exempted from the scope of registration. Also, substances imported or manufactured in an amount of less than 1 tonne per year are exempt from the scope of registration. Hence, there is no need to pre-register these substances.
Will Sigma-Aldrich communicate pre-registration numbers? Will I receive pre-registration numbers from Sigma-Aldrich?
Many customers have asked Sigma-Aldrich to provide them with pre-registration numbers for the products we supply. Following the recommendation from CEFIC, the European Chemical Industry Association, our policy is not to provide this information.
- There is no legal requirement to communicate pre-registration numbers in the supply chain
- A pre-registration number does not add any value. It cannot be tracked back either to the specific substance or to the Legal Entity submitting the pre-registration.
- Communication would cause unjustified bureaucratic efforts.
I am a user of Sigma-Aldrich products for research activities, what are my obligations under REACH?
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. If you manufacture a substance in excess of one tonne per year then the obligations shown in the flowchart must be considered
I am a European "Downstream User" (DU). How should I inform Sigma-Aldrich about my use/exposure?
One of the aims of REACH is to establish open communication along the supply chain. Nevertheless at the moment it is too early to inform Sigma-Aldrich about your use and exposure of a substance, as industry standards and tools for the communication of use and exposure are not yet finalized. The overall agreed approach is a top-down communication: The manufacturer or importer of a substance will collect all known uses and exposure scenarios and route them to his downstream users. Should your specific use not be covered in the proposal you may ask the supplier to support your use. We are participating in the project of drafting the supply chain communication process via Chemical Industry Associations (VCI & CEFIC). We will contact you regarding substance use and exposure when appropriate.
I am a non-EU customer of Sigma-Aldrich. How am I affected by REACH?
As a customer of SIAL 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 tonne per year have to be pre-registered/registered by the responsible importer. If you are served from a European subsidiary of Sigma-Aldrich all delivered products are REACH compliant, but due to the latest interpretation of the legal text by the European Commission a re-import to Europe is subjected to pre-registration. If you are served from a non-EU facility (e.g. Switzerland, North America, South America or Asia) of Sigma-Aldrich the delivered products are not subjected to REACH and cannot regarded as pre-registered. Although we will do our best we can't give any general commitment that the products supplied to non-EU customers are REACH compliant. 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! We also offer you to contact us for an individual analysis of your situation. Please also consider our SAFC offer for industrial customers.
Does REACH require any changes in the Safety Data Sheets (SDS) prepared according to the existing provisions?
The safety data sheet (SDS or MSDS) remains the main tool for hazard communication in the supply chain of chemical products. So far only minor changes have been implemented. At the moment there is no need to ask for a new SDS and you can continue to use the version on hand. We will update the SDS as new information becomes available and make it available for our customers.
What is the late pre-registration?
Even after the end of the pre-registration period (Dec 1, 2008), pre-registration is still possible if the manufactured/imported quantity of a phase-in substance should exceed the 1-tonne/year limit for the first time after December 1, 2008 (late pre-registration according to Article 28.6). This creates an advantage from the phase-in status, delaying the registration until the respective deadline is met.
Companies that did not manage to pre-register their substances in time must cease manufacture in the EU and can no longer sell here until they have submitted a full registration. However, companies that start to manufacture or import a substance in the EU above one tonne per annum are entitled to apply for a 'late pre-registration' of a substance that meets any of the three 'phase-in' criteria set out in Article 3.20 of the REACH Regulation provided that they do so within six months of passing the 1t/y limit and no later than 12 months before the scheduled registration deadline for the substance.
European Chemicals Agency FAQ
Last update: October 2009
DISCLAIMER: The information in this publication is given in good faith and is believed to be accurate. We do not accept any liability or responsibility whatsoever for the accuracy or completeness of this publication and do not make representation or warranty in relation thereto.
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