Your position in the supply chain
NON-EU
MANUFACTURERS AND TRADERS OF CHEMICALS
MANUFACTURERS AND
IMPORTERS OF CHEMICALS
MANUFACTURERS AND
IMPORTERS OF ARTICLES
NON-EU MANUFACTURERS AND TRADERS OF CHEMICALS
According to the REACH regulation (EC) No 1907/2006 substances on their own, in preparations or in articles shall not be manufactured in the Community or placed on the market unless they have been registered:
No data no market
Companies established in the EU can pre-register and register substances. Non-EU companies do not have any legal obligation under REACH. But they are affected because they shall support the EU-Importers with necessary information to fulfil their obligations.
There are three alternatives for non-EU manufacturers to ensure access to the EU market:
- Supporting of all Importers that import more than 1 tonne per year into the EU (delivery of valid data for the registration)
- Assigning an affiliate (established in the EU) as registrant
- Assigning an Only Representative (OR) (established in the EU)
When you choose the first option you depend on your EU-importers. The delivery of substance information or the composition of your preparations may cause a loss of confidential information. Furthermore, when the importer decides to change the supplier the non-EU supplier will lose market share.
The second option is a good alternative, when non-EU companies have their own subsidiary in the EU and the employees know the REACH regulation and can carry out the obligations under the REACH regulation. Assigning an affiliate as registrant would ensure confidentiality of business information and independence. EuDiCo can support you in preparing for REACH and in implementing the REACH processes in your business to fulfil your obligations.
The third possibility is to assign an Only Representative who fulfils the obligation on importers under the REACH regulation. In this case the non-Community manufacturer shall inform the importer(s) within the same supply chain of the appointment. Then these importers shall be regarded as downstream users for the purposes of the REACH regulation. EuDiCo offers the OR-service to ensure the non-EU manufacturers access to the Community market.
To ensure your access to the EU-market EuDiCo offers:
- an Only Representative service
- a support and consulting service
- a third party representative service for your EU affiliate
Non-EU distributors are not able under REACH conditions to contract an Only Representative, but in this case we offer special solutions.
Contact EuDiCo for more information
MANUFACTURERS AND IMPORTERS OF CHEMICALS
Tasks and duties of manufacturers and importers of chemicals:
- Establish a REACH TEAM and a REACH MANAGER
- Acquire REACH-KNOW-HOW
- Find out the impact of REACH on your business
- Develop an action plan including priorities and time frame
- Define tasks in detail:
- Compile and revise your substance and article inventory
- Define the substances for pre-registration
- …
- Pre-register the substances that are imported or manufactured in an annual amount of more than 1 tonne.
- Identify substances of very high concern because they may be subject to authorisation (restriction, authorisation)
- Prepare strategic decisions according to the registration of substances and your substance-portfolio
- Cost-evaluation
- Priority products/ top seller
- Substitution of substances/suppliers
- …
- Communication with suppliers
- Communication with customers
- Prepare a strategic decision according to your SIEF participation
- Take part in SIEF or
- Assign a 3rd PARTY REPRESENTATIVE to relieve your staff and to stay anonymous
- No active participation
- Co-operate with the other SIEF-members (e.g. consortium)
- Collect available data and studies needed for the registration (ownership!)
- Prepare your individual dossier
- Register your substances within the corresponding time frame
- Prepare REACH- and GHS-compliant safety data sheets (SDS)
Contact EuDiCo for more information
- Prepare strategic decisions concerning the communication of your uses to suppliers, pre-suppliers, manufacturers and importers:
- Communication of the own uses up the supply chain
- Keeping the own uses confidential
- If the manufacturer / importer does not include your uses in his Chemical Safety Assessment (CSA) you have the following alternatives:
- Perform your own downstream user chemical safety assessment resulting in a downstream user chemical safety report and compile and update the safety data sheet (SDS)
- Identify alternative suppliers established in the EU or non-EU suppliers that have assigned an Only Representative
- Identify an alternative non-EU supplier. Then you are an importer and need to register yourself.
- Search and use alternative substances
- Implement the risk management measures communicated to you via the safety data sheet for hazardous substances. In case of nonhazardous substances your supplier should deliver information for safe use.
- Transmission of the information of safe use to your customers
- Reformulation of preparations when substances are not available any longer (e.g. SVHC)
- Analyse your substance portfolio to evaluate the risk of SVHC.
Contact EuDiCo for more information
Trading goods within the EU, without import, does not require any registration duties under the REACH regulation.
Support of the communication "up" and "down" the supply chain is necessary.
To ensure the communication along the whole supply chain the co-operation of the distributors is important. To enable the manufactures to register their chemicals with special regard to clients´ applications (identified uses) the distributors have to transmit related customer information
Additionally the supply of information to customers with regard to registered usage is also important as well as information about the content of substance of very high concern in concentration of more than 0.1 % (w./w.).
Contact EuDiCo for more information
MANUFACTURERS AND IMPORTERS OF ARTICLES
Regarding articles REACH distinguishes between different cases:
In a case where:
- a substance is contained in an article in a quantity of more than 1 t/a per manufacturer / importer and
- the substance is not registered for the intended use and
- the substance is intended to be released
the tasks and duties are the same as for manufacturers
and importers of chemicals for the released substances since
June 2008.
In a case where:
- a substance is contained in an article in a quantity of more than 1 t/a per manufacturer / importer and
- the substance is not registered for the intended use and
- the substance is a substance of very high concern (CMR, PBT, vPvB etc.) and
- the substance is contained in the article in a concentration above 0.1 % (w./w.) and
- exposure cannot be excluded
From the beginning of June 2011 importers and manufacturers of articles are obligated to notify the substance to the agency, at the latest 6 months after the identification of the substance as SVHC.
Any supplier of an article containing a substance of very high concern (SVHC) in a concentration above 0.1 % (w./w.) provides the recipient of the article (mandatory) sufficient information to ensure safe use of the article, as a minimum, the name of that substance free of charge.
The relevant information shall be provided to consumers of the aricle on request free of charge within 45 days of receipt of the request
Prepare for your communication obligations. Article 33 governs the information that shall be given to recipients of the articles and consumers.
Contact EuDiCo for more information