1. Registration details
1.1. GENERAL APPROACHES IN CHEMICALS ASSESSMENT
- Manufacturers and importers need to collect or generate data on the substances.
- Manufacturers and importers need to assess how risks to human health and the environment can be controlled.
- The responsibility lies with the persons that manufacture, import, place on the market or use these substances.
- The identification of measures required to manage risks is an integrated part of the safety assessment concept.
- The aim is to demonstrate how risks identified for the manufacturing or use processes can be adequately controlled.
- The process includes an assessment of all available relevant information on the hazardous properties of a substance and on the conditions under which it is used.
- For substances that are manufactured or imported in volumes greater than 10 tonnes per year, a formal Chemical Safety Assessment* needs to be carried out. (details of chemical safety assessment please refer to registration guidance p12)
1.2. WHO HAS TO REGISTER?
1.2.1.Actors in the supply chain
Therefore, for each substance a company has to define its role or roles under REACH
Manufacturer: means any natural or legal person established within the Community who manufactures* a substance within the Community.
Note: Manufacturing: means production or extraction of substances in the natural state. It is a case by case decision to establish which steps of the synthesis of the end product lead to substances which need to be registered.
Importer: means any natural or legal person established within the Community who is responsible for import*.
Note: Import: means the physical introduction into the customs territory of the Community.
Downstream user: means any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities.
Note: Use: means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilization.
- European Economic Area (EEA) is composed of Iceland, Liechtenstein, Norway and the 27 EU Member States.
- Importer of a substance from an EEA country would not be required to register the substance under REACH and would simply be regarded as a downstream user.
- Importers of a substance from Switzerland will have the same obligations under REACH as any other importer.
Examples:A formulator purchasing his substances in Germany or Iceland will be considered as a Downstream User. A formulator purchasing his substances in Switzerland or Japan will be considered as an Importer.
1.3. SUBSTANCES, PREPARATIONS AND ARTICLES
- Substance means a chemical element and its compounds.
- Substances obtained by a chemical manufacturing process,
- Substances obtained in their natural state.
There are three types of substances: mono-constituent substances, multi-constituent substances and UVCB substances. (Details please refer to registration guidance p16)
- Preparation means a mixture or solution composed of two or more substances.
- Typical examples of preparations include paints, varnishes, and inks.
- Preparations can contain several substances.
- Preparations are not the same as multi-constituents substances.
- Within the Globally Harmonised System for classification and labeling (GHS), a preparation is named a “mixture”.
- Article means any object that has been given a specific shape, surface or design which determines its function to a greater degree.
- Only substances have to be registered, preparations or articles do not.
- When contained in a preparation, each individual substance needs to be registered when reaching the threshold of 1 tonne per year.
- On the other hand, substances that have been registered by the manufacturer or the importer do not need to be registered again by the downstream user.
- Individual substances in articles are also potentially subject to registration under certain circumstances as detailed in the Guidance for articles.
1.4 ACTORS IN THE SUPPLY CHAIN WITH REGISTRATION OBLIGATIONS
The only actors in the supply chain with registration obligations are:
- EU manufacturers and importers of substances on their own or in preparations.
- EU producers and importers of articles meeting the criteria explained in the Guidance for articles.
- EU-based “only representatives” appointed by a manufacturer, formulator or article producer outside the EU to fulfil the registration obligations of importers.
Only representatives of non-EU manufacturers
- Non-EU manufacturers can nominate an only representative located within the EU to carry out required registration of the substance they export to EU.
- The only representative will have to comply with all obligations of importers under the registration title of REACH.
An “only representative” should have:
- Sufficient background in the practical handling of substances;
- The information related to the relevant substances to fulfill the obligations of a registrant (importer).(Details of “Only Representative” please refer to registration guidance p19)
Example of when registration is needed:
· A manufacturer of a substance who uses the manufactured substance himself is a manufacturer and a downstream user. He has a duty to register each substance manufactured in quantities of 1 tonne or more per year, unless exemptions apply, and will have to include information on his own use(s) and any identified uses of his customers in his registration.
· An importer of a preparation has to register those substances which are present in the imported preparation in quantities of 1 tonne or more per year, unless exemptions apply. He will have to include information in his registration on the identified use(s) of the substance(s) in the preparation. There is no obligation for importers of preparations to register the preparations themselves; indeed preparations cannot be registered.
Example of when registration is NOT needed:
· Any person, who is using substances which he has not manufactured or imported, is a downstream user and has no obligation to register these substances.
· An importer of a substance, a preparation or an article, who is importing from a non EU company who has appointed an “only representative” will be considered as a downstream user and therefore does not need to register.
· A manufacturer or importer of a substance which is exempted from Title II of REACH has no obligation to register that substance.
1.5 WHO IS RESPONSIBLE FOR REGISTRATION?
· It should be noted that only a natural or legal person established in the European Union can be a registrant.
· A “natural person” is a concept refers to human beings who are capable and have the right to engage into contracts or commercial transactions.
· A “legal person” is a similar conceptrefer to companies who have been endowed with legal personality by the legal system applicable to them (the law of the Member State where they are established) and therefore are capable of carrying rights and obligations, independently of the people or other companies behind them (in the case of a “limited company”, their shareholders).
· In this guidance the term legal entity is used to refer to such a natural or legal person having rights and obligations under REACH. (Details of legal aspects please refer to registration guidance p20)
1.6 WHAT TO REGISTER?
1.6.1.Overview of registration scope
· Definition of a substance:
o Potentially hazardous industrial chemicals
o Every type of chemical substance manufactured in or imported into the EU
o Some substances which are regulated by other legislation will complete or partial exempt
· Registration requirement:
o Substances manufactured or imported in quantities of 1 tonne or more per year
o Apply to all substances no matter it is hazardous or not
o Prepare a technical dossier for all registrations
o Prepare a chemical safety report (CSR) for over 10 tonnes per year
o Prepare specific exposure information in the technical dossier for substance amount between 1 tonne and 10 toonnes per year
o Radioactive substances
o Substances under customs supervision
o Non-isolated intermediates
o Process and product oriented research and development (PPORD) require a notification
o Substances are considered as causing minimum risk to human health and the environment
§ Natural origin
§ Corn oil
§ See Annex IV and V
(Details of Exemption items please refer to registration guidance p27)
1.6.2.Calculation of the volume to be registered
· Rules to applied
o Registration dossier for phase-in and non phase-in substance (Article 3(30))
o How to calculate the volume
o What are the information requirements that have to be fulfilled
o When the registration of the substance is due
(Details of tonnage calculation please refer to registration guidance p24)
1.6.3.Substances exempted from registration
· Certain substances that are adequately regulated under other legislation
o Food or feeding stuffs
o Medicinal products
o Generally present such low risks as not to require registration (water, oxygen)
o Specific types of cellulose pulp
o Occurring in nature (minerals, ores and ore concentrates…)
o Polymers (not very hazardous)
(Details of Exemption from registration items please refer to registration guidance p30)
1.6.4.Substances regarded as registered
· Certain substances or uses of substance are regarded as being registered
126.96.36.199. Active substance for use in biocides
· The active ingredients are covered by Directive 98/8/EC (Biocidal Products Directive)
· Fulfilled the several conditions
1. The substance must be an active substance for use in a biocidal product
2. The substance must be included in on of the following:
§ Annex I to Directive 98/8/EC
§ Annex IA to Directive 98/8/EC
§ Annex IB to Directive 98/8/EC
§ Regulation (EC) No 2032/2003
· The same substance used in another non-boicidal product is not exempted
o A manufacturer manufactured 100 tonnes of quaternary ammonium compounds
o 50 tonnes are used as active substances in biocides and included in one of the acts mentioned under (2) above
o 50 tonnes are used as surfactants in cleaning products
o Only 50 tonnes active substances is exempted from registration
Legal references: Article 15 (2), Article 16, Article 56 (4) (b)
188.8.131.52. Active substance for use in plant protection products
· Regarded as registered as the plant protection products and their active ingredients and co-formulants are covered by Directive 91/414/EEC (Directive on plant protection products)
· In principle undergo a thorough assessment, on the basis of already submitted substantial information, before they an be placed on the market
· Several conditions have to be fulfilled:
1. The substance must be either an active substance or a co-formulant for use in a plant protection
2. The substance must be included in one of the following:
§ Annex I to Directive 91/414
§ Regulation (EEC) No 3600/92
§ Regulation (EC) No 703/2001
§ Regulation (EC) No 1490/2002
§ Decision 2003/565/EC
§ A commission decision on the completeness
· Manufacturers have to prepare a full registration dossier when put the same substance on the market but not for the purpose of biocides
o A manufacturer manufactured 100 tonnes of copper sulphate
o 50 tonnes are used as active substance in pesticides and the active substance is included in one of the acts mentioned under (2)
o 50 tonnes are used for another use
à50 tonnes which used for another use has to be registered
Legal references: Article 15 (1), Article 16, Article 56 (4) (a)
184.108.40.206. Notified substances according to Directive 67/548/EEC
· For new substances, which were substances not appearing on the European Inventory of Existing Commercial Chemical Substance (EINECS)
· Legal entities should check submitted a notification to a Member State competent authority or not
· Directive 67/548/EC require a substance that was placed on the EU market or imported into the EU to submitted a notificationàno need to registered under REACH
· For a substance manufactured in the EU, but not placed on the market, have to be registered under REACH
Legal reference: Article 24
1.7 WHEN TO REGISTER?
1.7.1 Phase-in substances vs. non phase-in substances
220.127.116.11 Phase-in substances
· A substances which already being manufactured or placed on the market before 1st June 2007 and were not notified according to Directive 67/548/EEC
àthe registration can be submitted within deadlines foreseen by the REACH
àthe registration can be submitted within deadlines foreseen by the REACH
· Phase-in substances mean the substances are being subject to the registration system in different phases over time, rather than immediately in one go
· The phase-in substance is being pre-registered within the 1st June 2008 and the 1st December 2008 (Phase-in substance criteria please refer to registration guidance p41.)
· The transitional regime for phase-in substances also applies to on-site and transported isolated intermediates
· Do not pre-register on time will not be able to benefit from the transitional regime
Legal references: Article 3 (20)
18.104.22.168 Non phase-in substance
· All substances that are not fulfilling any of the criteria for phase-in substances are considered as non phase-in substance
· Do not benefit from the transitional regime
· Need to be registered before they can be manufactured, imported or placed on the market in the EU
· Registration of non phase-in substances require the submission of an inquiry dossier first
o To determine whether a registration or another inquiry has already been submitted for the same substance
1.7.2 Deadlines for Registration
Legal references : Article 23
Legal references: Article 23