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FAQ focused on specific product ranges will be discussed during our workshops . . . Join SGS seminars!
- What is the difference between REACH and the present system of chemicals management?
- Which responsibilities will industry shoulder under REACH?
- What impact will REACH have on SME?
- How long will it take to register all chemicals under REACH?
- What is the difference between existing chemicals and new chemicals? Will both require testing?
- Will each registration require testing?
- Will REACH result in more animal testing?
- What is evaluation?
- What is authorization, and which types of chemicals will require authorization?
- If a substance is registered/evaluated/authorized, can it then be used in any field of application?
- Will the use of hazardous chemical substances be restricted or banned?
- Will chemicals in pesticides, pharmaceuticals and cosmetics be included in REACH?
- Will mixtures of chemicals (such as paint) have to be registered under REACH?
- Will chemicals in everyday articles have to be registered?
- Will articles that contain chemicals have to be labelled?
- What is the objective of GLP?
- Will consumers have access to the information on chemicals registered in the database?
1. What is the difference between REACH and the present system of chemicals management?
Under the present legislation public authorities are required to identify and address possible safety issues for the chemicals on the market. REACH aims to change this balance by requiring industry to take responsibility for assessing the risks of chemicals and for ensuring their safe use. At the same time, improvements in the efficiency of the system are designed to ensure that there are better incentives for developing new and safer chemicals and that the requirements are drawn up in such a way that the competitiveness of EU industry is safeguarded.
The Safety Data Sheets (SDS) used for transfer of information in the present system will continue to be used in REACH. The SDS are a well-understood, and internationally accepted tool for the communication of information about chemical hazards, risks, and risk reduction measures. SDS will be used as the primary communication tool for information developed under REACH.
Comparison between the present system and REACH:
| There are gaps in our knowledge about many of the chemicals on the European market. | REACH will close the knowledge gap by providing safety information about chemicals produced or imported in volumes higher than 1 tonne /year per manufacturer / importer. |
| The 'burden of proof' is on the authorities: they need to prove that the use of a chemical substance is unsafe before they may impose restrictions. | Burden of proof' will be on industry. It has to be able to demonstrate that the chemical can be used safely, and how. All actors in the supply chain will be obliged to ensure the safety of the chemical substances they handle. |
| Notification requirements for ‘new substances’ start at a production level of 10 kg. Already at this level, one animal test is needed. At 1 tonne, a series of tests including other animal tests have to be undertaken. |
Registration will be required when production/import reaches 1 tonne. As far as possible, animal testing will be minimized. |
| It is relatively costly to introduce a new substance on the market. This encourages the continued use of "existing", untested chemicals and inhibits innovation. | Innovation of safer substances will be encouraged under REACH through: more exemptions for research and development; lower registration costs for new substances; and the need to consider substitute substances for decisions on authorization and restrictions. |
| Public authorities are obliged to perform comprehensive risk assessments that are slow and cumbersome. | Industry will be responsible for assessing the safety of identified uses, prior to production and marketing. Authorities will be able to focus on issues of serious concern. |
2. Which responsibilities will industry shoulder under REACH?
The new legislation addresses manufacturers, distributors, importers and downstream users.
Manufacturers produce substances. Importers import substances from non-EU countries, and downstream users make industrial or professional use of chemicals. Distributors only store or place a substance on the market. Some of them mix chemicals to make preparations (such as ink), others use substances or preparations to make articles (such as ballpoint pens, chairs or cars), or use them in their business (such as CD-manufacturers who use degreasing agents to clean their machines).
The vast majority of the REACH requirements apply directly to manufacturers and importers of substances. They will supply data on the properties of their chemicals, develop chemical safety assessments and implement risk management measures.
Downstream users will be supplied with safety information about the chemicals they purchase and should follow them when handling the chemicals. They will also need to make sure that their customers (e.g. other industries and consumers) have all the information necessary to use their products safely. When a chemical is to be used in a way not covered by the original registration, the new uses or risk reduction measures will have to be reported to the Agency if the volume is higher than 1 tonne. Distributors must also ensure safety information is provided with the substances they sell.
3. What impact will REACH have on SME?
Small and medium-sized enterprises (SME) are a vital part of the EU chemicals industry. Since safety is a key concern, regardless of company size, the REACH information requirements relate to production volumes, uses and properties of the chemicals, and not to turnover or the number of employees of the companies.
Many of the SMEs that will be affected by the present legislative proposal are 'downstream users', i.e. companies that buy chemicals and use them as ingredients in their own products or use chemicals in an industrial or professional way. As a result of their position in the value-added chain, most chemicals will already be registered when they are used by downstream users. When assessing risks, manufacturers and importers must address the uses identified by downstream users. This will help to ensure a high level of chemical safety for downstream users and will reduce their costs. Downstream users who wish to keep their uses secret can choose to do their own risk assessments.
SMEs that are manufacturers will be able to take advantage of the incentives for innovation that the REACH system will create, such as:
- Exemption from testing requirements for substances used in product- and process- orientated research and development.
- No registration below 1 tonne.
- Light information requirements for low volume substances (registration threshold at 1 tonne/year per manufacturer/importer, normally only in vitro testing for substances between 1 and 10 tonne). This should reduce the costs for manufacturing SMEs, who will typically work in this range.
- Administrative burdens and costs can partly be shared between registrants in the pre-registration process.
4. How long will it take to register all chemicals under REACH?
Substances that are already on the market will be phased gradually into REACH.
Substances produced in high volumes and CMRs will have to be registered first. Registration deadlines will be calculated from the year the legislation enters into force so that the new obligations will apply from:
- Year 3.5 for high production volume chemicals (>=1,000 tonne or more/year/ manufacturer or importer), CMRs in volumes of 1 tonne or more and environmentally hazardous substances from 100 t/year;
- Year 6 for production volumes in the range of >=100 tonne;
- Year 11 for low production volume chemicals (>=1 tonne).
5. What is the difference between existing chemicals and new chemicals? Will both require testing?
Existing chemicals and new chemicals are the two types of chemicals defined under regulation 793/93/EC. The dividing line of these two types of chemicals is September 1981. Chemicals placed on the market before and after such date are named respectively as existing substances and new substances. There are a total of 100,106 existing substances and around 4,300 new substances to date.
Under present EU legislation, only the new substances are required to be tested and notified to the authorities before being placed on the market. For existing substances, the European Commission and Member States have so far prioritized 141 high volume chemicals for assessment since 1993, surprisingly only about 27% of them have been completed in more than 10 years time. Amount all high volume chemicals only 3% have been fully tested, the others are either with little data or with no testing at all. These figures show that a lot of chemicals are now being used without safety information and implies the degree of protection for human health and environment is inadequate which set the grounds for the EU environmental ministers to initiate the discussion of a new EU chemical policy in 1998.
6. Will each registration require testing?
No. There is already a lot of information available, and REACH accepts the submission of existing information. New testing will be required only where there is no sufficient information available and other sources of information are not appropriate. Registrants will be required to share animal testing data; this will avoid many new tests.
7. Will REACH result in more animal testing?
For low volume chemicals (1-10 tonne/year per manufacturer or importer), animal testing will be avoided as far as possible. For higher volumes, animal testing may be necessary if existing information and validated alternative methods are not sufficient. Testing programs involving animals, required for certain higher volume substances, need to be agreed with the competent authorities, through the evaluation procedure, before the experiments start. This is to ensure that the endpoints studied are relevant, that the scientific validity of the research is sufficiently high, and finally to ensure that the testing program is not duplicating other studies. To minimize duplicate testing, data sharing between enterprises will be required.
There are two types of evaluation: dossier and substance evaluation. Both evaluations will be performed by competent authorities in the Member States.
Dossier evaluation will be conducted to check proposals for testing on animals and ensure that unnecessary animal testing is avoided. Registration dossiers can also be subject to a dossier evaluation to ensure their compliance with the registration requirements.
Substance evaluations can be performed when there is reason to believe that a substance may present a risk to human health or the environment (for example, because of its structural similarity to another substance or for other reasons). Therefore, substance evaluations will look at all the registration dossiers submitted for the same substance and take into account any other available information. It is expected that substance evaluations will focus on those substances that may pose the greatest risk to human health and the environment. The Agency will develop risk-based criteria to assist with the prioritization of substance evaluations.
To help ensure that the system operates efficiently, a competent authority from one Member State will be designated in each case to carry out an evaluation based on rolling plans they will develop, setting out the substances they will evaluate. The outcome of an evaluation may be that the registrant(s) have to provide additional information, either to bring their registration into compliance with the requirements or to help clarify risks.
If all Member States agree to request more information, the Agency will take the decision. If not, the Commission decides whether or not more information should be requested.
9. What is authorization, and which types of chemicals will require authorization?
All substances of very high concern will be subject to authorization. Authorizations apply to particular uses of the substance in question. Authorization will be granted only if the producer or importer can show that risks from the use in question can be adequately controlled, or that the socio-economic benefits of the use of the substance outweigh the risks. All applicants for an authorization need to include an analysis of alternative and a substitution plan where a suitable alternatives exists.
The authorization decision will take into account substitution plans showing for example that the industry is researching substitutes. Third parties will also be able to provide information to the Agency about possible substitute substances or technologies.
Examples of substances that will be subject to authorization are:
- CMRs (carcinogenic, mutagenic or toxic to reproduction), category 1 and 2,
- PBTs (persistent, bio-accumulative and toxic),
- vPvBs (very persistent, very bio-accumulative).
- Substances identified as having serious and irreversible effects to humans and the environment equivalent to the other three categories, for example certain endocrine disrupting substances (substances disturbing the body's hormone system). These will be identified on a case by case basis and be subject to authorization.
10. If a substance is registered/evaluated/authorized, can it then be used in any field of application?
No, a substance is registered, evaluated and authorized for particular uses. Manufacturers who want to use the substance for another use must update their registration for this specific field of application. This further use may also be subject to authorization if it is a substance of very high concern.
11. Will the use of hazardous chemical substances be restricted or banned?
Many hazardous chemicals can be used safely if the right risk management measures are respected, such as the use of good ventilation or protective clothing. Under REACH, substances of very high concern will be subject to Authorization and any other substance may be subject to a Restriction. Restrictions are the safety net of the system. The Commission will be able to introduce restrictions at EU level for any substance that poses unacceptable risks, taking due account of socio-economic factors. Restrictions include banning uses in certain products, banning uses by consumers or even complete bans.
12. Will chemicals in pesticides, pharmaceuticals and cosmetics be included in REACH?
Some will, others will not. REACH has been designed to complement but not overlap with other EU legislation.
13. Will mixtures of chemicals (such as paint) have to be registered under REACH?
As the REACH system is substance based, it is the substances in the mixture (preparations) that will need to be registered, not the preparations themselves. When the preparation is sold, the safety information accompanying it will apply to the entire preparation.
14. Will chemicals in everyday articles have to be registered?
Most articles, e.g. shoes or textiles, contain chemicals. Some of these are potentially hazardous to environment and health, if they are released. Those substances that are intended to be released as part of the utility of the article (e.g. the ink in a cartridge) will need to be registered if they are classified as dangerous. The same tonnage thresholds and information requirements as for other substances apply. If the release is not intended as part of the functioning of the article, but happens anyway (e.g. formaldehyde released from fibreboard), the substance may have to be notified to the Agency, who will decide whether a registration is needed.
15. Will articles that contain chemicals have to be labelled?
Not necessarily, because all articles contain chemicals and most articles are safe. However, industry will have to show that their use is safe and this may involve labelling and instructions for safe use.
16. What is the objective of GLP?
According to 2004/10/EC, Good Laboratory Practice (GLP) is defined as a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. The main objective of GLP is to ensure test data produced by different laboratories can be mutually recognized so as to avoid repeat testing. GLP provides an assurance to regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments. Member States of the European Union have to take measures to comply with the principle of GLP when evaluating chemicals safety according to 67/548/EEC.
In addition to chemicals, GLP applies to all non-clinical health and environmental studies for registering or licensing cosmetic, pharmaceuticals, pesticides as well as food and feed additives.
17. Will consumers have access to the information on chemicals registered in the database?
Yes, much of the key safety information will be available on-line on the Chemicals Agency's website and more will be available on request. This website will be launched six months after the pre-registration period.
* (Glossary reference: http://ec.europa.eu/enterprise/reach/index_en.htm)
