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REACH Implementation
All manufacturers and importers of chemicals have a general obligation to submit a registration to the European Chemicals Agency for each substance manufactured or imported in quantities of 1 tonne or more per year per company (legal entity). In the registration dossier, they must identify the risks that are linked to the substances they produce and market and indicate how these risks are managed.
This obligation applies to substances as such and in mixtures. A special registration regime applies for substances in articles (e.g. manufactured goods such as cars, textiles, electronic chips).
Without registration, substances cannot be manufactured or imported into the EU ("No data no market").
Two registration deadlines for substances placed on the market above 1000 tonnes and 100 tonnes per company per year have already passed in 2010 and 2013, respectively.
The last REACH registration deadline of 31 May 2018 concerns substances that are manufactured in or imported into the EU above one tonne per company per year.
Key information for companies, especially SMEs
Leaflet “Chemical safety and your business”
Please see ECHA's registration webpages for more information on REACH registration and on the 2018 registration deadline.
ECHA and the Member States evaluate the information submitted by companies to examine the quality of the registration dossiers and the testing proposals and to clarify if a given substance constitutes a risk to human health or the environment.
Extensive information on the evaluation process, procedures and on the final decisions, as well as recommendations to registrants and the annual evaluation reports can be found on ECHA's website.
Evaluation decisions are normally taken by ECHA, following a unanimous agreement in the ECHA Member State Committee (REACH, articles 51 and 52). If such an agreement cannot be reached, the case is forwarded to the European Commission to prepare a draft decision, to be taken in accordance with the procedure referred to in Article 133(3) of REACH. This has happened in the following cases:
a) Substance evaluation
|
Substance |
EC number |
CAS number
|
Initial concern |
Decision date or status |
Decision no |
|
|
Polyhaloalkene |
468-710-7, |
754-12-1 |
2012 |
Environment/Hazardous degradation products; Exposure/Wide dispersive use;
|
|
|
|
2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)
|
229-962-1 |
6864-37-5 |
2015 |
Concern relating to potential endocrine disruption and reproductive toxicity |
In progress |
|
*CORAP : Community Rolling Action Plan
** MSC: ECHA Member State Committee
b) Dossier evaluation
|
Substance |
EC number |
CAS number
|
Description |
Decision date or status |
Decision no. |
|
Tris(2-hydroxyethyl)-1,3,5-triazinetrione (THEIC) |
212-660-9 |
839-90-7 |
Data gap on pre-natal developmental toxicity, adaptations not acceptable. |
In progress |
|
|
N-[3-(dimethylamino)propyl]methacrylamide
|
226-002-3 |
5205-93-6 |
Data gap on reproductive toxicity.
|
In progress |
|
|
Reaction mass of dimethyl adipate and dimethyl glutarate and dimethyl succinate |
906-170-0 |
/ |
Data gap on reproductive toxicity.
|
In progress |
|
|
Dimethyl ether |
204-065-8 |
115-10-6 |
Data gap on reproductive toxicity and pre-natal developmental toxicity |
In progress |
|
Testing proposal examinations and compliance checks addressing reproductive toxicity:
The Commission suspended the decisions until the Test Methods Regulation included EOGRTS (15 July 2014), the REACH Annexes VIII, IX and X on reproductive toxicity information requirements were amended (20 February 2015) and ECHA guidance was adopted. The last version of guidance is available here.
The Commission is currently processing the draft evaluation decisions that ECHA had referred to it. A common approach was established involving ECHA and the Member States.
|
Substance |
EC number |
CAS number
|
Decision date or status |
Decision no. |
|
Dichloromethylbenzene |
249-854-8 |
29797-40-8 |
9.2.2017 |
|
|
Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) esters, zinc salts |
270-608-0 |
68457-79-4 |
9.2.2017 |
|
|
Slags, phosphorus-manufg |
273-732-3 |
69012-32-4 |
9.3.2017 |
|
|
N-methylaniline |
202-870-9 |
100-61-8 |
9.3.2017 |
|
|
Bis(2,3-epoxypropyl) terephthalate |
230-565-0 |
7195-44-0 |
9.3.2017 |
|
|
2,6-dimethyloct-7-en-2-ol |
242-362-4 |
18479-58-8 |
30.5.2017 |
|
|
Tris [2-[2-(2-methoxyethoxy)ethoxy]ethyl] orthoborate |
250-418-4 |
30989-05-0 |
30.5.2017 |
|
|
2-piperazin-1-ylethylamine |
205-411-0 |
140-31-8 |
30.5.2017 |
|
|
N-vinylformamide |
236-102-9 |
13162-05-5 |
30.5.2017 |
|
|
2,2`-iminodi(ethylamine) |
203-865-4 |
111-40-0 |
30.5.2017 |
|
|
Polyethylenepolyamine |
268-626-9 |
68131-73-7 |
30.5.2017 |
|
|
Amines, polyethylenepoly-, triethylenetetramine fraction |
292-588-2 |
90640-67-8 |
30.5.2017 |
|
|
2,2'-(octadec-9-enylimino)bisethanol
|
246-807-3 |
25307-17-9 |
30.5.2017 |
|
|
3-trimethoxysilylpropyl methacrylate
|
219-785-8 |
2530-85-0 |
30.5.2017 |
|
|
Reaction mass of α,α-4-trimethyl-(1S)-3-cyclohexene-1-methanol and α,α-4-trimethyl-(1R)-3-cyclohexene-1-methanol and 1-methyl-4-(1-methylethylidene)-cyclohexanol
|
232-268-1 |
NS |
30.5.2017 |
|
|
triethoxy(2,4,4-trimethylpentyl)silane |
252-558-1 |
35435-21-3 |
30.5.2017 |
|
|
200 other substances |
|
|
In progress |
|
The Annexes to these Decisions are not made publicly available since they may contain confidential business information.
As indicated, the compliance check and testing proposal examinations are almost exclusively concluded in ECHA. However, the ECHA Member State Committee did not agree on the more than 200 cases regarding two generation reproductive toxicity (information requirements 8.7.3 of REACH Annexes IX and X). The disagreement was about which study should be requested and what would be the parameters for the request, given that the new OECD test guideline TG 443 on the "Extended One-Generation Reproductive Toxicity Study" (EOGRTS) would become the new standard test method. Hence ECHA referred over 200 draft dossier evaluation decisions to the Commission. Approximately two-thirds of these are testing proposal examinations, and one-third compliance checks.
Background information on the Extended One-generation Reproductive Toxicity Study (EOGRTS)
The necessity to require the Extended One-generation Reproductive Toxicity Study (EOGRTS) arises firstly from the legal obligation to reduce testing on vertebrate animals and the number of animals involved. Under REACH (Article 13(2)), the European Commission was obliged to amend the Test Methods Regulation and the REACH annexes in order to replace, reduce or refine animal testing. The Extended One-generation Reproductive Toxicity Study, when the second generation is not triggered, uses approximately 50% less animals compared to the currently required two-generation reproductive toxicity study. Hence it has good potential for reducing the number of animals used in high tier reproductive toxicity testing, one of the endpoints with the highest animal use.
Secondly, also the aim of human health protection necessitates the proposed modification. EOGRTS is scientifically superior to the two-generation reproductive toxicity study as it analyses a number of additional parameters (e.g. concerning effects of potentially endocrine disrupting chemicals), provides increased statistical power, and opens the possibility to optionally include additional cohorts to address potential developmental neurotoxicity and developmental immunotoxicity concerns. Due to this improved study design, the EU considers that this method is better suited to fulfil the objective of identifying adverse effects on reproduction and therefore better meets the requirements in terms of protection of human health provided for in REACH.
Most cases will be grouped in the Commission decisions but they will all be addressed individually to the registrants. The public version of final decisions will be published alongside other evaluation decisions on this page and on the ECHA information on chemicals pages.
Substances of very high concern will be gradually identified in the 'Candidate list' and eventually included in Annex XIV of the REACH Regulation. Once included in that Annex, they cannot be placed on the market or used after a date to be set (the so-called "sunset date") unless the company is granted an authorisation.
For more information: DG GROW or ECHA.
REACH includes a restriction process for certain substances of very high concern if they pose an unacceptable risk to health or the environment. Such substances may be limited or even banned, if necessary. The restriction is designed to manage risks that are not addressed by the other REACH processes or by other Community legislation.