DISTRIBUTORS COMMUNICATION IN THE SUPPLY CHAIN AND EXPOSURE SCENARIOS
What happens when relevant information is missing in the supply chain? What are Distributors’ responsibilities in this case?
1
CONTENTS INTRODUCTION ....................................................................................................................................... 2 FECC INTERPRETATION ON DISTRIBUTORS’OBLIGATIONS ........................................................................ 3 REACH REGULATION PROVISIONS THAT SUPPORT THE INTERPRETATION ................................................ 4 A.
TITLE I GENERAL ISSUES REACH DEFINITIONS .............................................................................. 4
B.
TITLE IV INFORMATION IN THE SUPPLY CHAIN ............................................................................ 4
C.
TITLE V DOWNSTREAM USERS .................................................................................................... 6
ECHA ANSWER THAT SUPPORTS THE INTERPRETATION ........................................................................... 7
The information contained in this document is intended only for guidance purposes. Whilst the document is provided in utmost good faith and has been based on the most accurate information currently available, is cannot be interpreted as legal advice. No representations or warranties are made with regards to its completeness or accuracy and no liability will be accepted by Fecc for damages of any nature whatsoever resulting from the use of or reliance on this information. This document does not represent the views of any company represented by the Fecc. Users/Members are reminded that the text of existing international, EU and/or national legislations are the only authentic legal reference.
European Association of Chemical Distributors |Rue du Luxembourg, 16b, 1000 Brussels, Belgium T: +32 (0)2 679 02 60 | F: +32 (0)2 672 73 | Website: www.fecc.org
2
INTRODUCTION One of the aims of REACH is to reduce the risk for the human health and the environment when they are exposed to chemicals. The way to reach in this objective is by gathering all the information relevant to the hazards and risks of the substance and further communicating this down the supply chain together with the substance itself, in the form of correct CLP labels and REACH compliant Safety Data Sheet including Exposure Scenarios, if required. However from time to time needs to be reminded who and when has to do what. In the last years, since the first REACH registration deadline, registrants have tried to comply with the new requirement on the information along the supply chain, especially the one related to Exposure Scenarios, but not all of them have succeeded yet in this effort for different reasons. Missing ESs from a manufacturer is not an unusual situation, on the contrary, it happens that regularly distributors receive SDS without ES for registered, hazardous substances. Nevertheless: • •
What happens if this information is missing in the supply chain? Do you, as a distributor, have a clear idea of what your obligations are under REACH regarding the communication of Exposure Scenarios along the supply chain?
If you are a distributing company that buys a chemical substance from an EU manufacturer company, stores and sells it to different downstream users in the EU, you should have this document in mind.
European Association of Chemical Distributors |Rue du Luxembourg, 16b, 1000 Brussels, Belgium T: +32 (0)2 679 02 60 | F: +32 (0)2 672 73 | Website: www.fecc.org
3
FECC INTERPRETATION ON DISTRIBUTORS’OBLIGATIONS 1. According to the REACH definitions the Distributor: • is the one who only stores and places on the market a substance. • is a supplier. • is not a Downstream User. • is not an Actor in the supply chain. 2. According to article 31, Requirements for safety data sheets •
As a supplier of a substance or a mixture, Distributor has to provide a safety data sheet.
•
Actors in the supply chain, who are required to prepare a chemical safety report have to provide the relevant exposure scenarios. The distributor is not an actor in the supply chain and is therefore neither required to prepare CSR and provide the resulting exposure scenarios.
When compiling his own safety data sheet the Distributor shall pass on relevant exposure scenarios. But this is not the case. 3. According to article 37, Downstream User chemical safety assessments and duty •
Downstream User has to comply with Article 37 and shall prepare a Chemical Safety Report for any use outside the conditions described in an exposure scenario.
•
Manufacturer, importer or downstream user have to comply with the obligations laid down in Article 14, regarding the CSR and ES.
•
The only obligation for distributors, in Title IV Information in the supply chain, is to pass the relevant information to the next actor or distributor up or down the supply chain but not that of preparing the CSR and ES.
European Association of Chemical Distributors |Rue du Luxembourg, 16b, 1000 Brussels, Belgium T: +32 (0)2 679 02 60 | F: +32 (0)2 672 73 | Website: www.fecc.org
4
REACH REGULATION PROVISIONS THAT SUPPORT THE INTERPRETATION A. TITLE I GENERAL ISSUES REACH DEFINITIONS Article 3 Definitions •
Distributor: means any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a mixture, for third parties;
•
Actors in the supply chain: means all manufacturers and/or importers and/or downstream users in a supply chain; =>Interpretation: Distributor, in the meaning of REACH, is not seen as an Actor in the supply chain.
•
Downstream user: means any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) shall be regarded as a downstream user; =>Interpretation: Distributor, in the meaning of REACH, is not a Downstream User.
•
Supplier of a substance or a mixture: means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a mixture, or a mixture =>Interpretation: Supplier, in the meaning of REACH, is Actors in the supply chain + Distributors.
B. TITLE IV INFORMATION IN THE SUPPLY CHAIN Article 31. Requirements for safety data sheets 1. The supplier of a substance or a mixture shall provide the recipient of the substance or mixture with a safety data sheet compiled in accordance with Annex II. => Interpretation: Supplier includes distributor so relevant for Distributor. 2. Any actor in the supply chain who is required, under Articles 14 or 37, to carry out a chemical safety assessment for a substance shall ensure that the information in the safety data sheet is consistent with the information in this assessment. => Interpretation: “Actor” does not include distributor, so it does not apply to Distributor.
European Association of Chemical Distributors |Rue du Luxembourg, 16b, 1000 Brussels, Belgium T: +32 (0)2 679 02 60 | F: +32 (0)2 672 73 | Website: www.fecc.org
5
7. Any actor in the supply chain who is required to prepare a chemical safety report according to Articles 14 [Chemical safety report and duty to apply and recommend risk reduction measures of TITLE II- REGISTRATION OF SUBSTANCES] or 37 [Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures of TITLE VDOWNSTREAM USERS] shall place the relevant exposure scenarios (including use and exposure categories where appropriate) in an annex to the safety data sheet covering identified uses and including specific conditions resulting from the application of Section 3 of Annex XI. => Interpretation: “Actor” does not include Distributor, so it does not apply to Distributor. Any downstream user shall include relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for identified uses. Any distributor shall pass on relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for uses for which he has passed on information according to Article 37(2).
Article 34. Duty to communicate information on substances and mixtures up the supply chain Any actor in the supply chain of a substance or a mixture shall communicate the following information to the next actor or distributor up the supply chain: A. new information on hazardous properties, regardless of the uses concerned; B. any other information that might call into question the appropriateness of the risk management measures identified in a safety data sheet supplied to him, which shall be communicated only for identified uses. Distributors shall pass on that information to the next actor or distributor up the supply chain. => Interpretation: Actors’ obligation to communicate is described separately from Distributors’ obligation to communicate. This underlines again the basic perception that Distributor in the meaning of REACH only pass on information and chemicals in the supply chain. The Distributor is not seen to be the one who draft the information for the chemical and then pass the information on.
European Association of Chemical Distributors |Rue du Luxembourg, 16b, 1000 Brussels, Belgium T: +32 (0)2 679 02 60 | F: +32 (0)2 672 73 | Website: www.fecc.org
6
C.
TITLE V DOWNSTREAM USERS Article 37. Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures 1. A downstream user or distributor may provide information to assist in the preparation of a registration. 2.
Any downstream user shall have the right to make a use, as a minimum the brief general description of use, known in writing (on paper or electronically) to the manufacturer, importer, downstream user or distributor who supplies him with a substance on its own or in a with the aim of making this an identified use. In making a use known, he shall provide sufficient information to allow the manufacturer, importer or downstream user who has supplied the substance, to prepare an exposure scenario, or if appropriate a use and exposure category, for his use in the manufacturer, importer or downstream user's chemical safety assessment. Distributors shall pass on such information to the next actor or distributor up the supply chain. Downstream users in receipt of such information may prepare an exposure scenario for the identified use(s), or pass the information to the next actor up the supply chain. => Interpretation: Distributor does not have the right to make a use known, but he is obliged to pass on received use information upstream.
3. For registered substances, the manufacturer, importer or downstream user shall comply with the obligations laid down in Article 14 either before he next supplies the substance on its own or in a mixture to the downstream user making the request referred to in paragraph 2 of this Article, provided that the request was made at least one month before the supply, or within one month after the request, whichever is the later. => Interpretation: Distributor does not have the obligation to comply with art 14 prepare a chemical safety report. 4. A downstream user of a substance on its own or in a shall prepare a chemical safety report in accordance with Annex XII for any use outside the conditions described in an exposure scenario or if appropriate a use and exposure category communicated to him in a safety data sheet or for any use his supplier advises against. => Interpretation: Distributor does not have the obligation to prepare chemical safety report in accordance with Annex XII.
European Association of Chemical Distributors |Rue du Luxembourg, 16b, 1000 Brussels, Belgium T: +32 (0)2 679 02 60 | F: +32 (0)2 672 73 | Website: www.fecc.org
7
ECHA ANSWER THAT SUPPORTS THE INTERPRETATION THE QUESTION A Distributor who only stores and places on the market a substance, on its own or in a mixture, for third parties, as defined under article 3 of the REACH Regulation, buys a substance from a registered EU Manufacturer. The Distributor receives from the supplier (Manufacturer) the Safety Data Sheet together with the substance but not the relevant Exposure Scenarios. So he passes the relevant information received, the SDS without the ES, down the supply chain to the third parties (Downstream Users). What happens to the missing ES? Who has the obligation to prepare the CSR and the relevant ESs? In our understanding and according to articles 34 and 37.2. of the REACH Regulation, a Distributor only has the obligation to pass the relevant information to the next actor or distributor in the supply chain, but there is no obligation for Distributors to prepare a Chemical Safety Report and the relevant Exposure Scenarios for the identified uses. According to article 37.3. of the REACH Regulation, for registered substances, the manufacturer, importer or downstream user shall comply with the obligations to prepare a CSR. We would like from ECHA to clarify the responsibilities of the different players regarding the communication along the supply chain and especially the ones related to the ES. We attach a document where the legal references and our interpretation are described in more detail.
THE ANSWER As you correctly point out in your question, the obligation to prepare a CSR lies with the manufacturers, importers and downstream users. Distributors do not have such an obligation. They do have the obligation to supply the ES when they receive it, which is a separate duty.
Please note that the texts of the BPR, CLP, PIC and REACH Regulations are the only authentic legal references and that the information in this message does not constitute legal advice. Use of the information remains under the sole responsibility of the user. The European Chemicals Agency does not accept any liability with regard to the use that the recipient may make of the information contained in this message.
European Association of Chemical Distributors |Rue du Luxembourg, 16b, 1000 Brussels, Belgium T: +32 (0)2 679 02 60 | F: +32 (0)2 672 73 | Website: www.fecc.org
8
European Association of Chemical Distributors Rue du Luxembourg, 16b | 1000 Brussels | Belgium T: +32 (0)2 679 02 60 | F: +32 (0)2 672 73 | Website: www.fecc.org
European Association of Chemical Distributors |Rue du Luxembourg, 16b, 1000 Brussels, Belgium T: +32 (0)2 679 02 60 | F: +32 (0)2 672 73 | Website: www.fecc.org