Prerequisites
Do you know the difference between an SDS and an E-SDS?
Do you know what an exposure scenario is according to REACH?
If you are not familiar with these notions, please see our key-notion page "What is an E-SDS?".
What do I have to do when receiving an e-SDS?
When receiving an e-SDS and a registration number for a substance, proceed as follow:
Step 1: Gather your information
Gather information on how the substrance is used by you and your clients
Step 2: Check if uses match
- Step 2a: Check if your uses are included in section 1.2 of the SDS and by the exposure scenatios.
- Step 2b: Assess if there is or not an obvious mismatch comparing your uses and the included in ES.
Example: you sell mass-consumption products but your supplier does not include mass-consumption selling in uses in exposure scenarios
Step 3: Check if all uses conditions match
- Step 3a: If your uses are included, compare security conditions that are detailed in Exposure Scenarios with updated uses conditions in your organistaion, and with the ones you know of your clients.
- Step 3b: Assess if there is or not an obvious mismatch between your conditions use and the ones detailed in exposure scenarios.
Example: The substance contained in your product is over 20% but the exposure scenario provided by your suppllier insures only a concentration inferior to 5%.
If you see any mismatch between step 2 and 3, it is up to you to act!
If any doubt, please do not hesitate to ask an expert for advice.
What should I do if my uses or conditions are not included?
In this case, you must either:
Ask you supplier to include your uses in his CSR an to provide updated Exposure Scenarios. It is necessary and mandatory that you give your supplier enough information about your uses and use conditions in order to allow him to sucessfully carry out the CSR update and management associated risks measures. usually, this requires a dialogue with your supplier. He must set up any changes based on your request for his next delivery (if your request is prior - at least a month- to the next delivery).
Adapt your activity to use conditions detailed in Exposur Scenarios, in other terms:
- Set up recommended security conditions that are related to your own procedures (at minimum)
- Adapt composition and conception of your products
- Recommend security conditions to your clients
Try to find another supplier who provides exposure scenarios adapted to your use if the current one is not willing to do it
Create your own CSR (Under certain conditions, see What are the conditions to avoid downstream users CSR?) for security uses and conditions. It is not necessary to submit it to competent authorities, but you must keep it update and available upon request if you are inspected. You must, as well, enclose Exposure Scenarios matching your own SDSs.
What are the conditions to avoid downstream users CSR?
You do not have to create a downstream users CSR if:
- None SDSs qre required for the substance (for example if the substance is not classified as dangerous)
- The substance is registered according to its tonnage < 10 t/an
- you use less than a ton of substance a year in total. In this case, you must identify and apply management associated risks measures appropriate where its is necessary
- The concentration of substances in your mixture is under the lowest threshold set up in REACH Article 14
- You use this substance exclusively in a R&D frame where risks for human health and environment are controlled adequately
How am I supposed to communicate downstream?
You can include Exposure Scenarios provided with e-SDSs.
You may:
- Include these information in the SDSs body or in Exposure Scenarios as an annexe.
- Forward to your client Exposure Scenarios that were provided, after having checked their consistence with your own SDSs
Good to know: if you receive an e-SDS with added dangers, you must inform your clients immediately.
When are the deadlines ?
Your deadline start from the day you receive an e-SDS with a registration number.
- If your uses are included and that you do not need to create your CSR, you have 12 months to set up use measures and appropriate associated risks management that have been given to you through the e-SDS. Do not forget to update your SDSs if there is any changes regarding associated risks management measures in mixtures that you supply.
- SIf your uses are not included, you have 12 months to create your own CSR and set up matching Exposure Scenarios. Do not forget to update your SDSs if there are any changes regarding associated risks management measures in mixtures that you supply.
E-SDS: need help?
If you need help or complementary information for your s-SDSs compliance, remember that EcoMundo takes care for you ofintegrating Exposure Scenarios in your SDSs helped by the CSR.
Regarding Exposure Scenarios compliance EcoMundo takes care for you:
- Analysing of your uses, if needed via a diagnosis on site
- Controlling if your uses are included regarding received Exposure Scenarios
- Drafting of the argument in case of inspection
- Organising and mananging of you e-SDSs
Do not hesitate to see our page dedicated to this problem.
Check our REACH registration services for 2018
EcoMundo is an expert service provider for REACH registration 2018 Our services include:
- REACH compliance Service
- REACH consulting Service
- REACH for non-EU manufacturer
- REACH Registration
- Only Representative (OR) service
- REACH Late pre-registration and inquiry process
- Representation of your interests within the SIEF and/or consortium.
- Negotiation on your behalf and purchase of the Letter of Access (LoA) from the Lead Registrant
- REACH letter of access
- Data exchange and drafting of your REACH IUCLID dossier.
- Submission of your REACH dossier to ECHA and follow-up until acceptance
- Delivery of your REACH certificate
- Regulatory watch when needed
Need a quote for REACH registration?
Contact us via phone: for North America please dial + 1 (778) 231-1607 or for Europe +33 (0)1 83 64 20 54 or email us: contact@ecomundo.eu
