Actors in the supply chain –
Roles and responsibilities under EU and GB REACH / CLP
An important issue for all ‘actors’ in the supply chain is designation of their roles and responsibilities. Communication of hazard and recommended risk management measures is legally required to allow safety to workers, consumers and the environment. All actors in the supply line carry responsibility and failure to communicate could lead to penalties by national Competent Authorities. Note that actors may have more than one role, depending on their activities.
The vagueness of REACH and CLP in terms of certain definitions allow for some flexibility and industry can use this flexibility to assign specific roles to those in specific points of a supply chain.
As an example, the legal texts do not define whether the importer is the shipping company, customs agents, the receiving warehouse, the sales agent or the recipient of the material. However, by the time the material is off-loaded from a truck at the site of use, someone in the supply chain will have had to put their hands up and declare themselves ‘importer’ for REACH and CLP. And of course, if a REACH importer, then it is sensible to be consistent with CLP.
The REACH and CLP Regulations (both EU and GB) share many common definitions.
REACH activities include Registration and provision of a Safety Data Sheet (SDS) and CLP requires classification and labelling and poison centre notification (EU only). The requirement for Transport classification and labelling is not directly affected by either regulation, but data generated during the REACH registration process and improved understanding of hazards may influence Transport issues.
The key point is that all parties in the supply chain know their roles and responsibilities and have ensured that effective and compliant communication has taken place.
Roles in the supply chain
Definitions are described below, noting that the definition under the terms of the legal text may differ from the use of these words in common language.
Manufacturer
The manufacturer is defined as the EU / GB legal entity synthesising a substance.
Under both REACH and CLP, the manufacturer is fully responsible for the identification of the substance, assessments of hazards and communication of risk management measures. The manufacturer is legally responsible for correct classification and labelling and the provision of an SDS if classified as hazardous, contains certain substances above specified limits or otherwise required.
The manufacturer must also ensure REACH Registration and/or CLP notification. Registration is required if manufacturing over 1 t per annum. CLP notification is required within one month of first placing the manufactured substance on the market if it is classified as hazardous.
The role as manufacturer is therefore clear and will include toll-manufacturers who produce substances under contract and it is the toll-producer responsible for the Registration and correct classification of substances leaving their site (even though the sponsoring organisation can be named on labels and SDS).
Note that blending / mixing chemicals is not a manufacturing process.
Importer
These definitions remain the same for each legal text and import is considered ‘physical introduction’ of the material into Europe. This term itself has led to considerable confusion as ‘introducing’ is not clearly defined. It is argued that those transporting within Europe are not introducing the material and the term needs to be clarified with the term ‘placing on the market’.
The definition allows for some flexibility which means that those in a supply chain between the ports and end user can define their own roles – however, each legal entity in this supply line must know their role and one of these legal entities will be ‘placing on the market’.
Placing on the market
Import is defined as placing on the market. This makes it essential that the importer appreciates that they are the placing on ‘the market’, even if they do not supply onwards, and ensures that all obligations for placement on the market are met. Irrespective of designations being made in the supply chain, consistency within the legal text and consistency between REACH and CLP is essential.
Note that goods used by the importer (ie considered placed on the market) need to be labelled for handling and use to meet worker protection regulations. National regulations on safe handling mean that it is necessary to ensure imported goods are suitably labelled in the correct language and with correct warning pictograms and statements to provide adequate communication to the workers. Many importers re-label on receipt of hazardous chemical products or request that the non-EU (or non-GB) exporter correctly labels.
Only representative
The REACH Article 8 is the only reference to a role that can be played by a non-EU / UK organisation (‘non-community manufacturer or formulator’) and it does not appear in the CLP Regulation. The Only Representative (OR) effectively takes on the role that an importer would have as a registrant and carries full legal obligations. One exception to this is that the OR pays fees relative to the size of the organisation appointing the OR and not relating to the size of the legal entity acting as OR.
Note that any contractual conditions when appointing an OR are secondary to their legal responsibility; contracts providing an OR with disclaimers may not be valid. An OR carries full responsibility for all parts of REACH, including passing on hazard information and correct Exposure Scenarios and other risk management details.
Irrespective of REACH, this does not make the OR an ‘importer’ under the terms of the CLP regulation and is why the OR is not responsible for CLP notification or labelling. Under CLP, the ‘importer’ is for those introducing onto the market and the OR does not have an obligation to notify (unless they themselves import a quantity of the substance) and the OR details need not be included on the labelling or on the SDS.
The legal entity that places an order to a non-EU / UK exporter, and receives a specific chemical substance registered by that supplier’s Only Representative is an ‘importer’ under CLP but regarded as a ‘downstream user’ of this substance within the scope of REACH. The implications for labelling and SDS provision are discussed below.
Note with separate EU and GB REACH, a UK-based supplier can appoint an OR in the EU and vice-versa.
Downstream user
The term downstream user covers any user (except final use by the general public – the ‘consumer’) that is not the importer or manufacturer for any particular substance. In REACH, this clearly means that it is someone who is not responsible for registration activities and an importer that does not need to register because the Registration is being covered by the Only Representative of the non-EU producer is also designated a ‘downstream user’.
In CLP there is no provision of Only Representatives to take on the responsibility of the importer, so importers remain as such under CLP, even if they are considered to be downstream users for REACH.
Distributor / Trader
REACH and CLP are consistent on this term, but the terms ‘trader’ and ‘distributor’ are used in industry without full regard to their meaning. Distributors are those who facilitate movement of goods between supplier and recipient and the term ‘trader’ is used in this guide as an organisation that buys and sells goods, but does not necessarily change the packaging.
However, the regulations do not describe those clearing Customs or handling/storage facilities explicitly; guidance would suggest that any EU legal entity that handles goods on behalf of importers without changing the goods in any way can consider themselves a ‘distributor’ in this context.
The distributor can in theory handle over 1 t of any substance without registration, letting the importers determine if individual tonnages are sufficient for registration. Obviously, the distributor cannot realistically consider themselves importer for CLP while stating that their customers are importers under REACH – consistency in the supply line is essential. For any substance, the trader or distributor needs to make it clear whether they are the importer or not.
Re-packing or re-labelling material is a ‘process’ and organisations doing this cannot claim to be a ‘distributor’.
Activities for each actor in the supply chain
Key activities that are the responsibility of different actors in the supply chain are outlined below. The ‘distributor’ can optionally do any of these steps, but by doing so, it will make them an ‘importer’ and then all responsibility of an importer will apply. For example, by making a CLP notification, they will then be an importer and find that REACH registration will apply (unless OR involved), that they will need to label for onward supply and provide an SDS.
Note that non-EU / UK legal entities have no legal part to play in this, other than appointing an OR and likewise, organisations considered as downstream users only have obligations to ensure correct labelling and a suitable SDS is provided by them to their own customers.
REACH registration
The need to register is clearly set out in the REACH legal text and official guidance; it is performed by EEA manufacturers (including toll or contract manufacturers), importers or Only Representatives of non-EEA producers. If an OR has given an importer authority under REACH to import directly or indirectly from their sponsoring non-EEA producer, then the importer assumes the REACH designated role of ‘downstream user’.
If a distributor decides to register, they are then an importer and other duties of importers will apply.
CLP notification
Manufacturers and importers need to notify, unless they have REACH registered. As CLP does not recognise the role of OR, importers covered by a REACH OR will still need to notify. However, once fully registered (pre-registered does not count), the importer does not have to notify as it has been already registered in the supply line. This last point is not explicit in the legal text.
Note that this part of CLP still stands in the UK, but there is no published list or equivalent to the Inventory in the EU. This may all change in the future as the UK works out the best way to record and communicate risk management for low-volume chemicals.
Poison Centre Notification (PCN)
This is something the UK is not taking part in (despite a scare when it was noted someone had initially forgotten to delete from the GB CLP text). In the EU, national poisons centres notification have been (mostly) replaced with an EU-wide system and importers in to the EU must ensure that full disclosure of components in hazardous mixtures is submitted through the PCN portal.
This means EU customers must have full details of mixtures unless agents make the submission on behalf of non-EU exporters to preserve confidentiality. Alternatively, non-EU exporters can support their EU customers by making submissions as ‘foreign’ users.
See page on PCN [link]
See official ECHA pages (opens in new page) https://poisoncentres.echa.europa.eu/about-us
Labelling for supply – CLP Onus rests entirely on manufacturers and importers.
The non-EU / UK suppliers have no legal role to play and there is no obligation for exporters to Europe to label containers correctly; however, correct labelling will provide a valuable customer service. Technically, UK suppliers to the EU do not have to worry about EU Regulations and vice-versa, other than to help their customers.
Free samples, products made by toll manufacturers and formulators, contract packaging activities etc are all part of ‘supply’ and correct labelling is needed. There is no lower quantity limit (although some derogations for small packs < 125 ml).
Supply of SDS
As with CLP, a supplier is someone in the supply chain and can include transfer from one site to another within an organisation (depending on legal entity status) and supply to third parties and will include provision of samples and goods produced under contract.
The OR is legally responsible for ensuring that the contents of the SDS and all hazard data, risk management recommendations, exposure estimates etc for the substances that they have Registered are communicated to the importers (designated ‘downstream users’ under REACH).
Summary of roles
The key point is that all parties in the supply chain know their position and have ensured that the imported chemical substance or mixture is compliant with the necessary regulations and that suitable hazard communication and risk management has taken place.
• Manufacturers in EU / UK have no choice in that all responsibility fall on them, even if they are contract manufacturing.
• Non- EU / UK exporters have no legal role to play regarding REACH or CLP, with the exception that Only Representatives can only be appointed by foreign producers.
• Importers must ensure that substances on their own or in mixtures are compliant with REACH and CLP. The role of importer is defined as the legal entity that places material on the European market, but the term ‘placing on the market’ is less clear, despite definitions being provided in the legal text.
• Importers are regarded as downstream user under the scope of REACH, if registration is being covered by their supplier’s OR
• Importers covered by a supplier’s OR for REACH are still ‘importers’ under the scope of CLP.
• The Only Representative carries full responsibility for ensuring full information is available on all hazard data and the details of the CSR and Exposure Scenarios developed within the CSR (where applicable). If the OR is a joint registrant, they must have access to the full lead dossier to fulfil this obligation. The CSR and Exposure Scenarios must be applicable to the importers and the uses by the importers.
• Non-EU / UK producers have no official role in SDS provision or labelling, but need to take a responsible role in cases not directly covered by the legal text, such as supplying mixtures where different ORs are covering different components.
• Importers of mixtures do have a legal obligation under worker safety and environmental regulations to not ‘place on the market’ (i.e. import) without access to adequate information to allow hazard and risk assessment.
Communication of hazards and risk management recommendations is legally required to allow safety to workers, consumers and the environment; all actors in the supply line carry this responsibility and failure to communicate may lead to penalties.