Environmental guidance for your business in Northern Ireland & Scotland

Manufacturers and importers of chemicals: REACH responsibilities

Manufacturers and importers of chemicals - REACH responsibilities

What you must do

If you manufacture or import into the European Union (EU) one tonne or more of a chemical substance in a calendar year, you must register it with the European Chemicals Agency (ECHA). This applies to chemical substances on their own, in preparations or mixtures, and may also apply to finished products or articles.

Some substances are exempt from registration under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation.

The deadline for registering chemicals under REACH depends on the type of substance and the quantities you are manufacturing or importing.

You will need to fully register both:

  • existing substances, known as phase-in substances, which are generally those substances already on the market
  • new or non phase-in substances, which don't meet the criteria for a phase-in substance.

The majority of phase-in substances are those listed in the European Inventory of Existing Commercial Chemical Substances (EINECS). Some other substances may also be phase-in substances, including no-longer polymers.

HSE: Full definition of phase-in substances

Make an inventory

You should make an inventory or list of the chemical substances that your business uses, supplies, manufactures or imports. This will help you understand your responsibilities and the impact REACH will have on your business activities.

HSE: Creating an inventory (PDF, 97K)

Register pre-registered phase-in substances

If you pre-registered chemicals with ECHA as a manufacturer or importer before 1 December 2008, you must fully register by the relevant key deadline.

If you missed this pre-registration deadline, you cannot continue to produce or import the substance until you have registered it with ECHA. You should contact the REACH compliance team immediately. Email the REACH compliance team at reachcompliance@hse.gsi.gov.uk.

The first full registration deadline was 1 December 2010 for any chemicals you manufacture or import in quantities of either:

  • 1,000 tonnes or more per year
  • 100 tonnes or more if the chemical is considered very toxic to aquatic organisms
  • 1 tonne or more if the substance is carcinogenic or a reproductive toxin.

If you missed this first full registration deadline you should contact the REACH compliance team immediately.

REACH registration key deadlines

Key deadline Type and quantity of chemical substance to be registered
1 June 2013 100 tonnes or more per year of any chemical substance
1 June 2018 1 tonne or more per year of any chemical substance

 

Reach registration 2018 represents the final deadline for the registration of phase-in substances which are manufactured or imported in quantities greater than 1 tonne per annum.

HSE: REACH Registration 2018

You must register chemicals online and submit data using the ECHA REACH-IT application.

ECHA: REACH-IT applications

If you manufacture or import into the EU more than 10 tonnes of a chemical substance in a year, you may need to carry out a chemical safety assessment. You must produce a chemical safety report to show the results of your assessment and submit it to ECHA as part of your registration application. REACH specifies that your safety assessment must include a:

  • human health hazard assessment
  • human health hazard assessment of physicochemical properties
  • environmental hazard assessment
  • persistent, bioaccumulative, and toxic (PBT), and very persistent and very bioaccumulative (VPVB) assessment.

For some substances, you should also carry out an:

  • exposure assessment (including a generation of exposure scenarios/or the identification of relevant use and exposure categories)
  • exposure estimation
  • risk characterisation.

ECHA: Chemical safety assessment information

Pre-register phase-in substances you manufacture or import for the first time

If you start to manufacture or import into the EU 1 tonne or more of a phase-in substance in a calendar year for the first time after 1 December 2008, you can make a late pre-registration with the ECHA. You must do this:

  • no more than six months after you begin to manufacture or import the phase-in substance
  • at least one year before the ECHA full registration deadline for the quantity and type of your chemical.

HSE: REACH pre-registration

Register non phase-in or new substances

A non phase-in or new substance under REACH is one that doesn't meet the criteria for a phase-in substance.

The first time you manufacture or import 1 tonne or more of a new or non phase-in chemical substance within a calendar year, you must register with the ECHA before you start to manufacture or import it.

ECHA: REACH registration guidance

You should make an inquiry about whether the substance has previously been registered to the ECHA before you start to register the substance. This is to enable data sharing with other registrants, particularly data from animal tests.

Classify and label chemicals

If you manufacture or supply chemical substances, products or mixtures, you must classify and label them according to the Classification, Labelling and Packaging Regulations (CLP) before you put them on the market.

HSE: Labelling and Packaging

HSE: Guidance on the CLP Regulations

ECHA: REACH labelling and packaging requirements

Substance Information Exchange Forums (SIEFs)

SIEFs enable businesses that have pre-registered the same chemical to share information. You should use SIEFs to make joint registrations. You will have been automatically added to a SIEF when you pre-registered.

HSE: Information on the Substance Information Exchange Forum (SIEF)

Further information

HSE: REACH Registration 2018

HSE: REACH guidance

European Chemicals Agency (ECHA): Factsheet - what you need to know

ECHA: REACH guidance

HSE: Classification and labelling guide

HSE: REACH - Contact us

In this Guideline

Does the REACH Regulation apply to your business?

Manufacturers and importers of chemicals: REACH responsibilities

Distributors and users of chemicals: REACH responsibilities

REACH - Substances of very high concern and restricted chemicals

REACH legislation

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