What it is
Penalties for breaking EU rules on chemical substances
BOE step 7 of 7 · PassedIt is a government bill. Introduced by the Government. It was introduced on 12 June 2009. Introduced by: Gobierno.
Official title: Government bill establishing the sanctioning regime provided for in the (EC) Regulations relating to the registration, evaluation, authorization and restriction of chemical substances and mixtures (REACH) and on the classification, labelling and packaging of substances and mixtures (CLP), and amending them.
Source: Congreso de los Diputados, file 121/000029· updated 11 Nov
Automatic summary, not yet reviewed
- This law creates the Spanish penalty regime for violations of two EU regulations: REACH, on registration, evaluation, authorization and restriction of chemical substances, and the one on classification, labeling and packaging of substances and mixtures.
- The autonomous communities supervise, inspect and sanction within their territory, although the State may act exceptionally for extraordinary gravity or urgency. Public administrations must also exchange information and coordinate.
- Both individuals and legal entities can be sanctioned. Violations are classified as minor, serious or very serious; very serious ones include manufacturing or selling substances without prior registration, or running tests on humans or non-human primates for classification and labeling purposes.
- The penalties are fines: up to €6,000 for minor violations, from €6,001 to €85,000 for serious ones, and from €85,001 to €1,200,000 for very serious ones. Very serious violations can also bring temporary closure of facilities for up to five years.
- Violations expire after one, three or five years depending on whether they are minor, serious or very serious, and the same applies to imposed penalties. The same facts cannot be punished twice, and criminal liability prevails over administrative liability.
- The penalty regime on classification, labeling and packaging of substances applies from December 1, 2010, and the one for mixtures from June 1, 2015. Until then, the previous penalty rules remain in force.
Who it affects
- Manufacturers and importers of chemical substances: They must meet the required registrations, notifications and labeling or face fines of up to €1,200,000.
- Downstream users and distributors: They must use substances safely, pass information along the supply chain and keep documentation.
- Autonomous communities: They are responsible for inspecting and sanctioning within their territory.
- General State Administration: It coordinates and may act exceptionally in cases of extraordinary gravity or urgency.
Words worth knowing
- Registro previo (prior registration)
- The duty to register a chemical substance with the European agency before manufacturing, importing or selling it.
- Ficha de datos de seguridad (safety data sheet)
- A document describing the hazards of a substance or mixture and how to use it safely.
- Prescripción (statute of limitations)
- The maximum period to sanction a violation or enforce a penalty; once it passes, no action is possible.
- Multas coercitivas (coercive fines)
- Fines imposed to force someone to comply with an order, separate from the main penalty.
It summarizes the law as published in the BOE. It is written by artificial intelligence and may contain mistakes: the official text is what counts. Read the official text · How we make summaries
Where it stands
How far did it get?
It took 7 of 7 steps. It reached BOE, and today it is passed.
- Introduced12 June 2009Someone registers the text in the Congreso.
- Admitted16 June 2009The Bureau of the Congreso accepts it and, for a members’ bill, the plenary decides whether to consider it.
- Amendments19 June 2009Groups propose changes.
- Committee14 October 2009A committee goes through the text in detail.
- Plenaryno dateAll 350 deputies vote.
- Senate16 December 2009The Senate can pass it, amend it or veto it.
- BOE18 March 2010It is published in the Official State Gazette (BOE) and comes into force.
See the 10 official steps on a timeline
Was there a plenary vote?
We have no plenary vote linked to this law in the Congreso’s data.
What happens next
What happens now?
It is law, or will be once published in the BOE. It comes into force on the date its own text sets.
The same initiative in the other chamber:
Sources
Where does all this come from?
- Congreso de los Diputados, file 121/000029
Official title, type, author, dates and stage.
Retrieved 11 November 2026
- BOE, BOE-A-2010-5293
The law as published.
Retrieved 11 November 2026
- The data comes from the open files of the Congreso, the Senate and the BOE, unaltered.
- Each deputy’s province is the one of their seat on the day of the vote.
- We only say “passed” or “rejected” when the majority needed is certain; otherwise we say which side had more votes.