Obligations of the REACH and CLP Regulations

Your responsibilities and obligations depend on your role in the supply chain. The descriptions of operators presented below will help you identify your role.

Note that you may have more than one role.

You are a manufacturer if you manufacture a substance in the EU.
You are an importer if you import a substance or mixture into the EU.
You are a producer of an article if you manufacture or assemble an article in the EU.
You are an importer of an article if you import an article into the EU.
You are a downstream user if you use a substance either on its own or in a mixture in your industrial or professional activities (e.g. a paint manufacturer and painter are examples of downstream users). You are also a downstream user if you re-import a substance exported outside the EU and registered in your supply chain either on its own or in a preparation into the EU, i.e. you are a re-importer. Furthermore, you are a downstream user when a manufacturer established outside the EU has appointed an only representative in the EU who is responsible for the importer’s obligations. A re-packager who transfers substances or mixtures from one packaging into another is a downstream user.
You are a distributor if you only store and sell substances or mixtures. Parties who rename and relabel substances or mixtures are distributors.

A substance means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.

A mixture means a mixture or solution composed of two or more substances.

An article means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.

OBLIGATIONS OF THE REACH AND CLP REGULATIONS PER ROLE

If you manufacture more than one tonne of a substance per year, you are probably required to register the substance with the European Chemicals Agency (ECHA). Registration is required for manufacturing a substance and placing a substance on the market. Mixtures composed of two or more substances are not registered.
You are responsible for the classification of the substance you manufacture. If your substance has been classified as hazardous, you must ensure that it has been labelled and packaged in accordance with the provisions before placing it on the market. In Finland, labelling must be in Finnish and Swedish. In addition, you need to submit classification information to the ECHA (classification and labelling notification) regarding a substance classified as hazardous, regardless of the manufactured amount. No separate classification and labelling notification is required for registered substances, as classification information is provided during the registration process.
Verify whether you are using or manufacturing substances subject to authorisation and act accordingly.
Check any restrictions on the manufacture, placing on the market or use of your substance, and follow them.
You may need to prepare a safety data sheet for the substance you manufacture and provide it to your customers. In Finland, safety data sheets must be in Finnish and/or Swedish, depending on the recipient of the chemical.
Also remember to submit a chemical notification to Tukes if your substance requires a safety data sheet.
Substances may also be governed by product-specific regulations.

If you import more than a tonne of a substance on its own or in a mixture into the EU, you are probably required to register the substance with the European Chemicals Agency (ECHA). A chemical can be a single substance or a mixture composed of two or more substances. In the case of a mixture, you need to identify the registration obligation for each substance contained by the mixture.
You are responsible for the classification, labelling and packaging of the substance or mixtute you import in accordance with the CLP regulation. In Finland, labelling must be in Finnish and Swedish.
If you import substances classified as hazardous either on their own or in a mixture, you must submit classification information to the ECHA (classification and labelling notification), regardless of the imported volume. No separate classification and labelling notification is required for registered substances, as classification information is provided during the registration process.
If an imported mixture is hazardous to health or presents a physical hazard, you must submit a notification to the Poison Information Center and add the UFI code to the warning label.
Verify whether you are using or manufacturing substances subject to authorisation and act accordingly.
Check any restrictions on the manufacture, placing on the market or use of your substance, and follow them.
You may need to prepare a safety data sheet for your substance or mixture and provide it to your customers. In Finland, safety data sheets must be in Finnish and/or Swedish, depending on the recipient of the chemical.
Also remember to submit a chemical notification to Tukes if your substance or mixture requires a safety data sheet.
Substances and mixtures may also be governed by product-specific regulations.

If a substance that is unnecessary for the use of an article such as a perfume is intentionally released through the use of the article, and the annual volume of the substance in the articles you manufacture or import is more than one tonne, you need to register the substance with the European Chemicals Agency (ECHA).
If an article contains more than 0.1% by weight of a substance of very high concern (SVHC), and the annual volume of the SVHC in the articles you manufacture or import is more than one tonne, you need to submit a notification of the SVHC to the ECHA.
If an article you supply contains more than 0.1% by weight of an SVHC, you need to submit a notification to the ECHA’s SCIP database and provide your customers with information on the SVHC to enable the safe use of the article.
If you use a substance subject to authorisation in the manufacturing of articles, you will need an authorisation for its use.
If any restrictions have been set for the substances contained by your article, you need to follow the terms and conditions defined in the restrictions. The use or placing on the market of a substance in articles may involve concentration limits, or a substance may be prohibited.
More information on obligations and derogations is available in the ECHA guidance on requirements for substances in articles.
Articles may also be governed by product-specific regulations.

If you manufacture mixtures, you must classify, label and package them in accordance with the CLP regulation before placing them on the market. In Finland, labelling must be in Finnish and Swedish. In addition, you need to submit a notification to the Poison Information Centre regarding any mixtures classified as hazardous or presenting a physical hazard and add the UFI code to the warning label. Re-packagers are also required to submit a notification to the Poison Information Centre unless the supplier’s notification covers the information required regarding the re-packager.
You can only use a substance subject to authorisation if an authorisation is granted to you or an applicant up your supply chain. If an authorisation has not been granted to you, you need to submit a notification of use to the European Chemicals Agency (ECHA).
Check any restrictions on the substances you use and follow them.
If you manufacture mixtures, you may need to prepare a safety data sheet and provide it to your customers. In Finland, safety data sheets must be in Finnish and/or Swedish, depending on the recipient of the chemical. Also verify whether you need to submit a chemical notification to Tukes if a safety data sheet is required for the substance or mixture.
If you use a substance on its own or in a mixture in a way other than in accordance with the exposure scenario specified in the safety data sheet given to you, you must prepare a downstream user chemical safety report. You must submit a downstream user’s notification to the ECHA if you prepare a chemical safety report or use an exemption from it.
More information on obligations and derogations is available in the ECHA guidance for downstream users.
Substances and mixtures may also be governed by product-specific regulations.

You must ensure that substances and mixtures have been labelled and packaged in accordance with the CLP regulation before placing them on the market. In addition to the labelling requirements for substances and mixtures classified as hazardous, a substance classified as hazardous contained by a mixture may present labelling requirements for a mixture not classified as hazardous. In Finland, labelling must be in Finnish and Swedish.
For mixtures classified as hazardous to health or presenting a physical hazard, you must verify that a notification to the Poison Information Center has been submitted appropriately. If the information is incomplete regarding a mixture you have renamed or relabelled, you must ensure that the notification is submitted with correct information.
Check any restrictions.
As the supplier of a substance or mixture, you must provide a safety data sheet with your contact information to your customers. In Finland, safety data sheets must be in Finnish and/or Swedish, depending on the recipient of the chemical.
Verify whether you need to submit a chemical notification to Tukes if a safety data sheet is required for the substance or mixture.
Substances and mixtures may also be governed by product-specific regulations.

Obligations of the REACH and CLP regulations in a table

Obligations	Manufacturer	Importer	Producer or importer of an article	Downstream user	Distributor
CLP: Classification of substances and mixtures			(substances, explosive articles)		-
CLP: Labelling and packaging			(explosive articles)
CLP: Substance classification and labelling notification			-	-	-
CLP: Notification of a mixture to poison centres	-		-		-
REACH: Substance registration			(intended release of substances)	-	-
REACH: Applying for an authorisation for the use of a substance			(producers)		-
REACH: Notification of the use of a substance subject to authorisation	-	-	(producers)		-
REACH: Compliance with bans and restristions
REACH: Preparing a safety data sheet			-		-
REACH: Providing a safety data sheet			-
REACH: A downstream user chemical safety report and a notification of preparing the report or being exempted from the report	-	-	(producers)		-
REACH: Submitting a notification of an SVHC contained by an article to the ECHA	-	-		-	-
REACH: Notifying customers of an SVHC contained by an article	-	-	-	-
WFD (Waste Framework Directive): SCIP notification of an article containing an SVHC	-	-	-	-	(suppliers of articles)
Data retention period of ten years