REACH FAQs

 REACH FAQs

A. The ABCs of REACH

  1. Does REACH affect businesses outside the EU?
  2. How has REACH changed or affected previous chemical regulations?
  3. How has REACH changed or affected the way chemicals are managed or regulated?
  4. What are the deadlines for REACH compliance?
  5. My company is not based in the EU but my goods are imported/used in the EU. Who can help me to register my goods under REACH?
  6. Why should non-EU businesses use an “Only Representative”?
  7. How should I prepare for REACH?
  8. My company exports polyurethane belts to EU customers. We do not manufacture them in the EU. Are we affected by REACH?
  9. Who can I contact if I have a question on REACH?

B. Substances Affected By REACH

  1. What are “substances of very high concern”?

C. REACH Obligations

  1. Who are “Downstream Users” under REACH? How are they affected by REACH?
  2. Are “Downstream Users” who are not in the EU affected by REACH?

D. Pre-Registration

  1. What information is required for pre-registration of substances under REACH?
  2. What are “phase-in substances"? How do I know if my substance is considered “phase-in”?
  3. Are there any fees for pre-registration?
  4. Why should I pre-register substances?
  5. Why does REACH have a pre-registration period? What is the purpose of pre-registration?
  6. What happens if I miss the pre-registration period for my “phase-in” substances?
  7. What is a Substance Information Exchange Forum (SIEF) and how is it formed?

E. Registration of Substances

  1. What information is required for registration of substances?
  2. The depth of information required for registration depends on the tonnage imported into the EU. How do I find out what information is required for the various tonnages?
  3. What is the minimum information required for registration? Where can I find this list of information requirements?
  4. Are there any fees for registration of substances?
  5. What substances are exempted from registration? Is there a list that I can refer to?
  6. My substance is exempted from the registration under REACH. Does that mean my products do not need to comply with REACH? Or that I have no obligations under REACH?

F. Registration of Substances in Articles

  1. What are articles?
  2. Do I have to register substances in articles?
  3. There are “substances of very high concern” in my articles? Do I need to notify the European Chemicals Agency? If so, when?


A. The ABCs of REACH


1. Does REACH affect businesses outside the EU?

Yes, REACH affects :

  • Manufacturers, exporters and distributors of any chemicals, chemical preparations or products containing chemicals which end up in the EU.
  • Buyers and users of chemicals, chemical preparations or products containing chemicals made in the EU.
  • Businesses that process chemicals for EU customers.
Example 1 : Singapore Manufacturer of Chemicals

ABC Pte Ltd is a Singapore manufacturer. ABC’s products – chemicals – are imported into the EU. Under REACH, these products may have to be registered or authorised before they can continue to be imported into the EU.

Example 2 : Singapore Exporter of Products

ABC Pte Ltd is a Singapore exporter. ABC exports products containing chemicals (e.g. toys) to the EU. Under REACH, the chemicals in these products may have to be registered before the products can continue to be imported into the EU.

Example 3 : Singapore Buyer of Chemical Products Made in the EU

ABC Pte Ltd is a Singapore company that makes products. ABC buys chemical-based products from the EU. Under REACH, the EU manufacturer must ensure that these chemical products are registered or authorised so they can be continually manufactured in the EU and exported to ABC.

Non-EU businesses should, therefore, familiarise themselves with REACH and its obligations if they have dealings with the EU market. Non-EU businesses may be required to provide information to help their EU customers comply with REACH so that their goods can continue to be imported or used in the EU.

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2. How has REACH changed or affected previous chemical regulations?

REACH replaces some 40 chemical regulations and creates a single system for the regulation of chemicals.

The need for REACH arose as pre-REACH laws were not effectively regulating chemicals and fostering the development of new chemicals.

Pre-REACH, businesses had to distinguish between "existing" and "new" chemicals based on the cut-off date of 1981.

Existing chemicals (approximately 100,000 reported) required no testing before marketing. New chemicals, on the other hand, had to be tested rigorously.

As a result, little was known about the hazards of existing chemicals and the development of new chemicals was significantly hindered.

REACH not only dispenses with the distinction between “existing” and “new” chemicals, but also introduces efficient processes for registration, evaluation and authorisation of chemicals.

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3. How has REACH changed or affected the way chemicals are managed or regulated?

REACH has shifted the responsibility of identifying health and environmental risks caused by chemicals and ensuring their safe use to EU businesses. Pre-REACH, public authorities were largely responsible.

REACH imposes obligations on all players of the supply chain in the EU, including downstream users, to show that risks posed by chemicals can be adequately controlled and to recommend measures to ensure their safe use. Previously, chemical regulations were targeted mostly at manufacturers and importers of chemicals.

With REACH, we will be able to collect, store and share data on hazardous properties of chemicals and the risks they pose. The sharing of information reduces the need for unnecessary animal testing.

REACH also promotes the development of “safer substances”. EU businesses are required to consider substitutes when seeking authorisation to use substances of very high concern (SVHC), authorities may impose restrictions on SVHC if substitutes are available, and more exemptions are given for substances that are used for research and development.

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4. What are the deadlines for REACH compliance?

All EU businesses must comply with REACH as of 1 June 2007 – the day the regulation entered into force. The deadlines for registration of substances are spread over 11 years.

Substance Registration Deadlines
1 Jun 2008 Registration of New Chemicals
All new chemicals must be registered before they are placed in the EU market.
1 Jun 2008 –
1 Dec 2008		 Pre-Registration of Phase-In Substances
Existing chemicals must be pre-registered so that they can be “phased-in” later.
30 Nov 2010 1st Phase-In Substance Deadline
Deadline for manufacturers and importers to register :
  • substances in quantities of 1,000 tonnes and above
  • carcinogens, mutagens and substances toxic to reproduction (CMR Category 1 and 2) above one tonne/year
  • substances classified as very toxic to aquatic organisms (R50/53) above 100 tonnes
31 May 2013 2nd Phase-In Substance Deadline
Registration deadline for manufacturers and importers of chemical substances in quantities of 100 tonnes and above.
31 May 2018 3rd Phase-In Substance Deadline
Registration deadline for manufacturers and importers of chemical substances in quantities of 1 tonne and above.


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5. My company is not based in the EU but my goods are imported/used in the EU. Who can help me to register my goods under REACH?

There are several options available to you. You can :
  1. Get the importer of your goods in the EU to register your goods for you. EU importers are obligated under REACH to register chemicals/products imported into the EU.
  2. Appoint an “Only Representative” in the EU to register your products for you and help you to ensure your goods can be continually imported and used in the EU.
An “Only Representative” can help you to :

  • fulfil all REACH obligations on your behalf
  • help your EU customers (e.g. importers) fulfil their REACH obligations
  • keep an inventory of goods imported and sold in the EU
  • inform your EU supply chain of the appointment
  • keep confidential information away from competitors and customers

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6. Why should non-EU businesses use an “Only Representative”?

There are several advantages of appointing an “Only Representative” to register your goods for you under REACH and to ensure your goods can be continually imported into or used in the EU.

  1. Your EU importers will be freed from the obligation of having to register your goods. They will appreciate the convenience and will have “peace of mind” that your supplies will not be disrupted.
  2. You are not dependent on your EU importers to register your goods under REACH. If they fail to register your goods in time, your supplies to the EU will be disrupted.
  3. You will have more control over the information disclosed as part of the REACH registration process. You can avoid disclosing confidential or sensitive information to your EU importers and competitors.
In a nutshell, an “Only Representative” based in the EU can help you to :
  • fulfil all REACH obligations on your behalf
  • help your EU customers (e.g. importers) fulfil their REACH obligations
  • keep an inventory of goods imported and sold in the EU
  • inform your EU supply chain of the appointment
  • keep confidential information away from competitors and customers

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7. How should I prepare for REACH?

Businesses with presence in the EU

You need to comply with REACH obligations. The obligations imposed depend on the role your business plays in the EU market (e.g. manufacturer, importer or downstream user).

To find out more about REACH obligations and what you have to do, please see :

Pre-Registration and Other REACH Processes
By: European Chemicals Agency (ECHA)

Complying with REACH – A Guide for SMEs
By: Export Technical Assistance Centre (ETAC), SPRING Singapore

Non-EU businesses with EU customers

As REACH obligations are not imposed on non-EU businesses, you should mainly be concerned about how these obligations affect your EU customers and do what is necessary to ensure your goods can be continually imported or used in the EU.

The first thing you need to do is decide if you are going to :
  1. Get your EU importer/distributor to register your goods for you, OR
  2. Appoint an “Only Representative” to register your goods for you.
To make the decision, you may wish to :
  • Make an inventory of goods (including the tonnage) which end up in the EU and determine if they need to be registered under REACH.
  • Discuss with your EU importer/distributor to determine the best way to fulfil REACH obligations and prepare any information your EU importer/distributor might need.
  • Scout around for services offered by “Only Representatives” in the EU.
For more information, please download :

Complying with REACH – A Guide for SMEs
By: Export Technical Assistance Centre (ETAC), SPRING Singapore

Non-EU businesses with EU Suppliers

REACH obligations are imposed on EU businesses – including your EU suppliers. You should contact your EU supplier to find out of the goods they supply to you must be registered under REACH.

If so, you might want to find out what their compliance plans are so that you can ensure that your supplies from the EU are not disrupted.

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8. My company exports polyurethane belts to EU customers. We do not manufacture them in the EU. Are we affected by REACH?

Yes. Although you have no obligations under REACH, your EU customers will need to comply with REACH.

Polyurethane belts are considered as “articles” under REACH Regulation (EC 1907/2006) and may be subjected to registration, notification and authorisation under REACH.

If so, then you will need to provide your EU customers with the information they need (e.g. hazard data and safe use information).

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9. Who can I contact if I have a question on REACH?

Businesses in Singapore can contact the Export Technical Assistance Centre (ETAC). ETAC runs education seminars and technical workshops on REACH and also has resources to connect you to REACH consultants for one-on-one assistance.

Export Technical Assistance Centre (ETAC)
SPRING Singapore
Tel: (65) 6279 3807
Fax: (65) 6271 3861
Website: http://www.spring.gov.sg/etac
E-mail: etac@spring.gov.sg

You may also wish to contact the European Chemicals Agency (ECHA) if you are registering substances under REACH. The ECHA Helpdesk also assists registrants with questions on REACH provisions, IUCLID 5, dossiers, etc.

European Chemicals Agency (ECHA)
Annankatu 18
00120 Helsinki
Finland
Tel: (358) 968 6180
Website: http://echa.europa.eu

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B. Substances Affected By REACH


10. What are “substances of very high concern”?

Substances of very high concern (SVHC) are :
  • carcinogens, mutagens and substances toxic to reproduction (CMR category 1 and 2)
  • persistent, bio-accumulative and toxic (PBTs) substances as set out in Annex XIII
  • very persistent and very bio-accumulative (vPvBs) substances as set out in Annex XIII
  • any other substance identified and backed by scientific evidence as being equally dangerous to human health or the environment (e.g. endocrine disruptors)
The list of SVHC will be out in January 2009 and will be listed in Annex XIV. These substances must be authorised under REACH before they can be made, imported or used in the EU.

See:
Authorisation of Substances, Chapter 4
Complying with REACH – A Guide for SMEs
By: Export Technical Assistance Centre (ETAC), SPRING Singapore

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C. REACH Obligations


11. Who are “Downstream Users” under REACH? How are they affected by REACH?

A “Downstream User” is described in the REACH Regulation as any party that uses chemicals in the EU :
  • to make preparations (e.g. paints, glues and detergents)
  • as part of industrial processes (e.g. oils, lubricants and antifoams)
  • as part of your profession (e.g. cleaners)
  • to produce articles/products (e.g. toys and cars)
REACH imposes obligations on Downstream Users. Under REACH, Downstream Users must :
  1. ensure their uses of any REACH-registered chemicals are reported
  2. submit notifications to the European Chemicals Agency under certain conditions
  3. obtain authorisation to use substances in Annex XIV that have not been authorised
  4. comply with restrictions posed on substances listed in Annex XVII
  5. communicate hazards posed by chemicals they used up and down the supply chain
  6. follow Risk Management Measures in suppliers’ Safety Data Sheets
  7. classify and label “dangerous substances” and those registered under REACH

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12. Are “Downstream Users” who are not in the EU affected by REACH?

Yes. Even though REACH does not impose any obligations on non-EU Downstream Users, they may still be affected by REACH.

Example 1: Singapore Buyer of Chemical Products Made in the EU

ABC Pte Ltd is a Singapore company that makes products. ABC buys chemical-based products from the EU. Under REACH, the EU manufacturer must ensure that these chemical products are pre-registered, registered or authorised as required so they can be continually manufactured in the EU and exported to ABC.

Example 2: Singapore Company that processes chemicals from EU Companies

ABC Pte Ltd is a Singapore company that processes chemicals for EU companies. The pre-processed chemicals are supplied by the EU companies. Under REACH, these EU companies must ensure that the pre-processed chemicals are pre-registered, registered or authorised as required so that they can be supplied from the EU to ABC.

Example 3: Singapore Company that processes chemicals for import into the EU

ABC Pte Ltd is a Singapore company that processes chemicals. The pre-processed chemicals come from many different countries. After the chemicals are processed, they will be imported into the EU. Under REACH, these processed chemicals must be pre-registered, registered or authorised as required so that they can be continually imported into the EU.

See:
Reach Obligations - Downstream Users of Chemicals, Chapter 2,
Complying with REACH – A Guide for SMEs
By: Export Technical Assistance Centre (ETAC), SPRING Singapore

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D. Pre-Registration


13. What information is required for pre-registration of substances under REACH?

To pre-register a substance, you need to submit the following information :
  • identity of the substance
  • contact person of the registrant
  • projected date of registration
  • tonnage manufactured or imported

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14. What are “phase-in substances"? How do I know if my substance is considered “phase-in”?

Phase-in substances are defined in Article 3(20) of the REACH legislation. Your substance will be considered a phase-in substance if the substance is :
  • listed on the European Inventory of Existing Chemical Substances (EINECS); or
  • already produced in the EU but not placed on the EU market; or
  • already produced and placed in the market at least once in 15 years before REACH entered into force; or
  • not a polymer but used to be considered a polymer under Directive 67/548/EEC until the 7th amendment

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15. Are there any fees for pre-registration?

Pre-registration is free – there are no fees imposed for the pre-registration of substances.

Fees, however, will be imposed on the registration of substances as of 1st June 2008 – the day that all substances must be registered in the EU before they can be made, supplied or used in the EU unless they are pre-registered.

In other words, the registration fees will immediately affect registrants of substances that cannot be or are not pre-registered. The registration fees imposed depend on the tonnage produced and sold in the EU every year.

See:
Schedule of Fees and Charges Payable under REACH (PDF)
Commission Regulation EC 340/2008
By: European Commission

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16. Why should I pre-register substances?

You will have more time to register your substances.

Under REACH, all substances must be registered from 1 June 2008 before they can be made, imported or used in the EU market.

If you pre-register your substances, you do not need to register your substances by 1 June 2008. Instead, you only need to register your substances when the deadline for your pre-registered substance is reached. The deadlines for registration of pre-registered substances are spread over 11 years.

You will have more time to prepare the information required to register your substance (i.e. the information required in the registration dossier).

Please note that pre-registration is only for “phase-in” substances, i.e. existing substances. You cannot pre-register any new substances.

The period for pre-registration is 1 June 2008 – 1 December 2008. Any “phase-in” substances that are not pre-registered by 1 December 2008 cannot be made, imported or used in the EU market until they are registered.

In a nutshell, pre-registration allows you to continue manufacturing, importing, using and placing in the EU market existing substances until the “phase-in” registration deadlines are reached.

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17. Why does REACH have a pre-registration period? What is the purpose of pre-registration?

The main reasons for pre-registration under REACH are :

  1. To provide businesses with more time to register existing substances.
    Businesses can continue to make, import and use existing substances until the “phase-in” registration deadlines are reached.
  2. To facilitate data-sharing among businesses.
    Businesses who pre-register will become part of the Substance Information Exchange Forum (SIEF). Through the SIEF, businesses can :
    • find other registrants of the same substance
    • share testing data
    • appoint a party to register the chemical on behalf of all registrants
    • agree on classification and labelling of substances

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18. What happens if I miss the pre-registration period for my “phase-in” substances?

If you do not pre-register your “phase-in” substances within the pre-registration period (1 June 2008 – 1 December 2008), you cannot make, import or use these substances in the EU as of 1 December 2008 until these substances are fully registered with the European Chemicals Agency (ECHA).

In other words, once you miss the pre-registration period, you must register your substances immediately with the ECHA if you wish to make, import or use these substances in the EU market.

Please note that it will take at least 3 weeks for your substance to be registered from the date you submit the registration dossier.

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19. What is a Substance Information Exchange Forum (SIEF) and how is it formed?

The Substance Information Exchange Forum (SIEF) is a forum that allows :

  • potential registrants of the same “phase-in” substances to share data and prepare for registration
  • downstream users and other interested parties who have data on substances to share the data with potential registrants if they are willing to do so
  • members of the substance supply chain to come together and agree on the classification and labelling of substances
By facilitating data exchange, SIEF aims to avoid duplicate testing and reduce unnecessary testing, especially on vertebrate animals. This will, in turn, help to reduce costs of registration for industry players.

SIEF is formed by the Europeans Chemicals Agency (ECHA). There will be 1 forum for each pre-registered substance with the same chemical identity. The list of all pre-registered substances can be found under the official REACH website by Euporean Chemicals Agency (ECHA).

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E. Registration of Substances


20. What information is required for registration of substances?

The information corresponding documentation required depends on the quantity of the substance and the level of risk the substance poses to humans and the environment.

Tonnage

Documentation Required
≥ 1 tonne per year Technical Dossier
≥ 10 tonnes per year Technical Dossier
Chemical Safety Report
≥ 100 tonnes per year Technical Dossier
Chemical Safety Report
Testing Proposal
≥ 1000 tonnes per year

For details on the information required for registration of substances, please visit the official REACH website by the European Chemicals Agency (ECHA).

See:
Registration Requirements, Chapter 4.1
Complying with REACH – A Guide for SMEs
By: Export Technical Assistance Centre (ETAC), SPRING Singapore

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21. The depth of information required for registration depends on the tonnage imported into the EU. How do I find out what information is required for the various tonnages?

You can refer to Annex VI – XI of the REACH legislation to find out what information is required.

Tonnage Documentation Required Relevant Annexes
≥ 1 tonne per year Technical Dossier VI, VII
≥ 10 tonnes per year Technical Dossier
Chemical Safety Report 		VI, VII, VIII
≥ 100 tonnes per year Technical Dossier
Chemical Safety Report
Testing Proposal		 VI, VII, VIII, IX
≥ 1000 tonnes per year VI, VII, VIII, IX, X

For details on the depth of information required, please visit the official REACH website by the European Chemicals Agency (ECHA).

See:
Registration Requirements, Chapter 4.1
Complying with REACH – A Guide for SMEs
By: Export Technical Assistance Centre (ETAC), SPRING Singapore

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22. What is the minimum information required for registration? Where can I find this list of information requirements?

The minimum information required for registration :
  • identity of the manufacturer/importer
  • identify of the substance
  • information on the manufacturer and identified uses of the substance
  • classification and labelling of the substance
  • guidance on safe use of the substance
The minimum information requirements are set out in Annex VI.

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23. Are there any fees for registration of substances?

Yes, fees will be imposed on the registration of substances as of 1st June 2008 – the day that all substances must be registered in the EU before they can be made, supplied or used in the EU unless they are pre-registered.

The registration fees imposed depend on the tonnage produced and sold in the EU every year.

Impact of Registration Fees

The registration fees will immediately affect registrants of substances that cannot be or are not pre-registered.

Registrants of pre-registered substances will feel the impact of the registration fees only when they register these substances, i.e. in 2010, 2013 and 2018.

Exemptions & Reduced Fees

No fees will be charged for the registration of substances in quantities of 1 – 10 tonnes per year provided that the Registration Dossier submitted contains the full information required/set out in Annex VII.

In addition, reduced fees will be set for small and medium enterprises (SMEs) who register their substances.

See:
Schedule of Fees and Charges Payable under REACH (PDF)
Commission Regulation EC 340/2008
By: European Commission

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24. What substances are exempted from registration? Is there a list that I can refer to?

The following types of substances are exempted from registration :
  • medicinal products
  • food or feeding stuffs
  • substance considered to cause minimum risks
  • substances inappropriate for registration
  • identical substances re-imported within the same supply chain
  • recovered substances which have been registered already
  • transported isolated intermediates
  • polymers 4
4 Polymers are, for the time being, exempted from registration. The European Commission will reconsider this in the coming years. The basic constituents (the monomers), on the other hand, must be registered. This includes the bound (or reacted monomers).

You may also refer to Article 2, Annex IV and Annex V for a list of exempted substances.

You should also be aware that these substances are outside the scope of REACH :
  • substances under customs supervision (re-exported)
  • transport of substances in the EU
  • substances used exclusively in the interest of defence
  • substances used exclusively as non-isolated intermediates 5
  • waste
  • radioactive substances
5 Non-isolated intermediates are transient substances that exist only at a point in time in a manufacturing process. They are not manufactured as chemicals and are not released/removed from the process in which they are created.

See:
REACH Regulation (EC No 1907/2006) Article 2: Application

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25. My substance is exempted from the registration under REACH. Does that mean my products do not need to comply with REACH? Or that I have no obligations under REACH?

No. You may still need to comply with other obligations or requirements under REACH. The obligations or requirements that apply depend on :
  • the characteristics of the substance (e.g. “dangerous”)and its use in the final product in the EU
  • your role (e.g. manufacturer, importer or downstream user)
  • if you need to update your registration dossier with ECHA
Example:
If you make or import a “substance of very high concern”, the substance must be authorised under REACH – even if the substance is exempted from registration. The quantity or tonnage of the substance is also irrelevant.

See:
REACH Regulation (EC No 1907/2006) Article 2: Application

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F. Registration of Substances in Articles


26. What are articles?

The definition of an article, found in Article 3 of the REACH legislation, is an object that has a specific shape, surface or design which determines its function to a greater degree than its chemical composition.

Toys, for instance, would be considered articles. A toy’s main function is determined by its shape, surface and design and not by the substances within.

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27. Do I have to register substances in articles?

Yes, you must register substances in articles if you are the producer or importer of the article and when all of these 3 conditions are met :

  1. One tonne or more of a substance, as a component of the articles, will be placed in the EU market every year
  2. The substance in the articles will be released under normal conditions of use.
  3. The substance has not already been registered for that use.

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28. There are “substances of very high concern” in my articles? Do I need to notify the European Chemicals Agency? If so, when?

You must notify the European Chemicals Agency about “substances of very high concern” in your articles if you are the producer or importer of the articles and when all these 3 conditions are met:

  1. The article produced/placed in the EU market contains “substances of very high concern” listed on Annex XIV above the permitted levels (≥ 0.1% w/w).
  2. The substance is present in the article produced/placed in the EU market in quantities of 1 tonne or more a year.
  3. The exposure of the substance to humans or the environment cannot be excluded.
The obligation to notify the Agency starts from 1 June 2011. Thereafter, producers and importers of articles need to submit notifications six months from the date a substance has been placed on the authorisation list. 175 substances have been notified by 2 June 2011.

See:
http://echa.europa.eu/reach/sia/notification_in_sia_en.asp
Last Modified Date :09 May 2012