Registration, Evaluation, Authorization and Restrictions of Chemicals
|Statement from Steve Walton
||"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."
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
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
|Sigma-Aldrich USE COMMUNICATION
When is use communication not necessary?
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 & chemical synthesis Sigma-Aldrich has thoroughly evaluated our own uses and those of our customers. In addition we have aligned our results with other main distributors and manufacturers. If your company is using Sigma-Aldrich products in the fields described above your use will probably be covered.
An overview of these supported uses can be found here. Please check thoroughly to confirm that your use is covered. You only need to contact us if your use for a specific product is not covered. For this purpose you can also download our excel template here for easy and structured communication. Please consider that we are only able to process product or substance-related information in such a structured format using ECHA’s Use Descriptor System (Guideline R12).
The completed spreadsheet can be sent to the following mail address:
REACHfirstname.lastname@example.org (this e-mail box should only used for use communication)
Please note that risk assessments of uses under REACH are only required for products containing substances that are classified as hazardous. Use information is not required for products, which are not classified as hazardous, or for substances that are produced in quantities of less than 10 tonnes per year. The majority of our catalogue products are in this low tonnage range.
The “safe use of chemicals” is a central aim of REACH. The risk assessment of their uses is the 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 has to be submitted to the ECHA with the dossier as part of the registration 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.
More information can be found in this ECHA document: Guidance in a nutshell on Chemical Safety Assessment
When is use communication not necessary?
In this respect a use communication is not needed for substances which are not classified as dangerous according to Directive 67/548/EWG resp. Regulation EC/1272/2008 (CLP-Regulation). A use communication for substances registered in the tonnage band 1-10 tonnes per year is also not needed, because no CSA/CSR is required for registration.
Use mappings from downstream user organizations (DUCC) can be very useful. They can be used as a library to find typical exposure scenarios for a certain activity. But as such they are not suitable for a substance-specific communication according to Art. 37(2) of REACH.
Sigma-Aldrich can only accept and electronically forward information about use which lists, for each substance, only the individual applicable use descriptors. For the description of uses the latest version of the ECHA 'Guidance on information requirements and chemical safety assessment - Chapter R.12' should be consulted
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 taken into account 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.
If your use is not covered, you have the following options:
- Implement an ES which includes as a minimum the conditions described in the ES communicated in the eSDS
- Check if one of the exemptions described in Art. 37(4) REACH legislation applies to you
- Make the use known to your supplier within 12 months after receiving the eSDS
- Create your own downstream user Chemical Safety Report within 6 months
During this time, it is legal to continue the use of the product
|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?
Before communicating your use and exposure scenarios please read the following. In most of the cases you use is already covered.
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) 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.
What about GHS/CLP?
While REACH and GHS/CLP have different scopes there are also many links between these regulations. Please have a look at our GHS Webpage. On this page you will have an overview about GHS/CLP and how Sigma-Aldrich implements this new Globally Harmonized System.
Are the products delivered by Sigma-Aldrich 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 here.
Publication of this list imposed duties on industry. The main duties are:
- According to Art. 33 any supplier of an 'article' (= finished product) containing a candidate substance in a concentration above 0.1% w/w has to provide information to allow safe use to his end users. On request he has to 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 have to 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.
Our lab equipment articles are currently under revision and Sigma-Aldrich will provide you with relevant information if needed.
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).
Please remember that it is your obligation as a downstream user to verify the information provided within an SDS and to determine if your application of a substance for your specific use is allowed or whether it is subjected to any other use restriction (for example Annex XVII of REACH).
The inclusion of a substance in the candidate list is the first step to authorization. After the evaluation process a candidate list substance will 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.
More information about authorization can be found here.
More questions and answers can be found at the ECHA:
European Chemicals Agency FAQ
Last update: July 2010
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.