The Chemical Act 2008 and 2010 facilitate the administration and enforcement of certain EU regulations on chemicals and dangerous substances. In particular, this includes
- the registration, evaluation and authorization and restriction of chemicals [REACH] regulation 2006;
- The classification labelling and packaging of substances and mixtures (CLP) regulations 2008;
- The Rotterdam Regulation on the import and export of dangerous substance under the Rotterdam Convention;
- The Detergents regulation.
The Regulations being EU primary law, take direct effect in Ireland. They are also directly applicable in other EU states.
The administrative and enforcement arrangements under the Chemicals Act are broadly similar to those in the Safety, Health and Welfare of Work Act. They are administered by the health and safety authority. A number of other authorities have subsidiary responsibility in under the legislation. they include the Department of Agriculture, Environmental Protection Agency, Revenue Commissioners, Irish National Accreditation Board, and Beaumont Hospital Board.
Under the REACH regulations all participants in a chemical supply chain are responsible for ensuring that they manufacture, place on the market and use substances in a way that does not adversely affect human health or the environment. The regulations place obligations on manufacturers, importers, representatives, distributors and users. All imports into the EU or manufacturers of greater than one tonne per annum, must be registered. Registration is on a phased basis. Registration deadlines depend on the tonnage and hazard posed by the substance. Key dates arise in 2010, 2013 and 2018.
Each participant in the supply chain must communicate and keep information. The authorisation scheme aims to ensure that substances of high risk are controlled and progressively replaced by suitable alternative substances or technologies, where this is technically and economically viable. Where this is not possible, substances may only be used where it can be demonstrated that they can be adequately controlled or where there is an overall benefit to society from using the substance. Substance which create an unacceptable risk to human health or the environment, are prohibited EU wide.
The CLP regulations relate to the classification, labelling and packaging of chemical substances and mixtures manufactured or imported into the EU. It is directly applicable to all participants in the supply chain down to the downstream user. There are criteria to determine whether a chemical causes human health or damage to the environment. The physical properties must be identified, and evaluated. The effect on health and environment must be identified. Hazards must be communicated on a label. The identification, evaluation and communication process must be made for any chemical manufactured, imported or placed in the market in the EU. All marketed chemicals must be classified and labelled.
Manufacturers and importers must notify their substance which have been placed on the market, through the classification and labelling inventory. The database is established by the European Chemicals Agency. It contains basic classification and labelling information on notified and registered substances.The notification obligation applies to substances within the scope of the regulation. This is those classified as hazardous, either in themselves or in a mixture, regardless of quantum. A substance which is subject to registration, must also be notified. The CML inventory is published online.
The Rotterdam Regulation relates to the import and export of dangerous chemicals. It provides for prior informed consent procedure for hazardous chemicals and pesticides which are traded internationally. It is effective as and from 2008.The Regulation places obligations on exporters of hazardous chemicals, when they export outside the EU. This allows third countries to monitor and control the export and import of hazardous chemicals.
The Regulation provides for shared responsibility and cooperative efforts in the movement of hazardous chemicals internationally. The principle of the Regulation is that banned or severely restricted chemicals, may be imported only with the prior informed consent of the importing party. There are more general obligations applicable to all chemicals on import.
Under the legislation, the Minister may make regulations to give effect to the EU rule. Regulations may be made in relation to the manufacture, classification, labelling, packaging, import, export, placing in a market, testing, storage, transport, use and disposal of chemicals. Regulations may also be made in relation to major accidents, hazards relating to chemicals and to the prevention of accidents involving chemicals and the minimisation of the effects of such hazards on persons and on the environment.
The HSA is to review the relevant chemicals statutory provisions as directed, from time to time and make proposals to the Minister. The HAS must consult with persons and bodies who appear to be appropriate, or as directed by the Ministers.The HSA may draw up codes of practice. Where the Minister directs, they may approve codes of practice developed by other bodies, which set out practical guidelines for compliance with the relevant chemical regulations provision.
National authorities are obliged to cooperate under the above legislation. Co-operation includes carrying out inspections, examinations, investigations, sharing information. National authorities are required to submit a report annually to the HSA.
Inspection and Administration
The HSA may appoint inspectors for the purpose of enforcement of provisions relating to chemicals. Inspectors are given certificates and evidence of identity. Inspectors have powers under HSA legislation and also under regulatory legislation generally. Inspections may be made, where there appear to be a contravention of the relevant provisions.
Inspectors may enter, examine and search any place where they reasonably believe relevant chemicals are situate. They are empowered to carry out tests, examinations and analysis of chemicals found. They may require that the samples be given for testing to the inspector.
Where the inspector considers it necessary to exercise the power, the test is carried out in the presence of the person in charge of the relevant place, if he requests to be present. Inspectors may remove and retain chemicals for examination, in order to ensure that they are not tampered with before examination or to ensure that they kept for evidence in legal proceedings.
Where an inspector removes and retains the chemical, the inspector must insofar as practicable, take a sample and give a marked and identifiable portion to the person in charge. An inspector may require the removal from the market of a chemical, where it appears that the relevant legislation has been contravened. When requested, the person in charge must give the inspector the name and address of the supplier from whom the chemical was purchased or otherwise obtained.
An inspector may issue a direction for an improvement plan, where he is of the opinion that an activity is being carried out that involves risk to human health or the environment. A written direction may be given, requiring the submission of an improvement plan. The direction must identify the activity, require a plan within one month, require implementation of the plan and include other requirements as the Minister considers necessary.
The inspector must within one month of receipt of the plan, confirm whether he is satisfied. Where he is not satisfied, he must direct the person who prepared the plan to revise it as specified in the direction. If satisfied with the plan, it is confirmed and the person submitting it is obliged to implement it.
Where there is a breach of a relevant chemical statutory provision and the person in control has failed to comply with a direction above or has failed to submit not an approved plan, a contravention notice may be served. The contravention notice will state the inspector’s opinion giving reasons and identifying the relevant legislation.
The contravention notice may give directions as to the necessary measures required to rectify the position. It will direct the person to remedy the contravention within a period, which may not be earlier than 14 days, or to remove the chemical from the market. It must set out information in relation to appeal procedures and certain other requirements. It must be signed by the inspector.
Where the person on whom the notice is served confirms that the matter has been rectified, he may give notice. The inspector is satisfied as to compliance, may so confirm. A person on whom a contravention notice has been served may appeal to the District Court within 14 days. The judge may vary, alter or cancel the notice.
A prohibition notice may be served by an inspector, prohibiting an activity relating to a chemical, where there is a serious risk of health to persons or the environment. The inspector may serve a prohibition notice if the measures taken by the person in control, for the prevention and mitigation of the major accidents, are seriously deficient.
The prohibition notice gives reasons for the opinion, states the breach and statutory basis, and prohibits the carrying on of the activity concerned until the matters are rectified and are signed. The notice may set out directions regarding matters which must be done, in order to rectify the contravention.
A prohibition notice may take place immediately or when an appeal is taken on the later of the day, next following the confirmation of the appeal or on the withdrawal of the appeal. An appeal does not suspend the prohibition notice, unless the court specifically so directs, on application made in that regard. A person may appeal to the District Court within seven days, the District Court may vary, confirm, annul or suspend the orders.
Where an activity gives rise to a prohibition notice and it is continued contrary to the notice, the inspector may apply to the High Court for an injunction prohibiting the activity. This will be appropriate where there is a serious risk to health, to the environment or where there is a potential to cause a major accident, due to breach of the prohibition notice. The High Court may on an ex parte one-sided application prohibit contravention of a prohibition notice. It may continue the order having heard the parties and may ultimately grant a permanent injunction.
Prohibitions and restrictions on the importation and the exportation of chemicals apply for the purpose of customs legislation. They can be, accordingly, enforced by customs officer. The HAS may disseminate information in the public interest relating to matters giving rise to contravention and prohibition notices. This may include information about a chemical of high concern including toxic, flammable and explosive chemicals.
The HSA may publish the names of persons
- convicted under the legislation;
- on whom prohibition notices have been served or
- in respect of whom, High Court orders have been made on the basis of contraventions.
There is a provision protecting persons who report breaches of the legislation. It prevents victimization and adverse employment consequences for reporting breaches of legislation. A complaint may be made to a Rights Commissioner on the basis of victimization.
The HSA may serve a notices on persons, requiring information required for the purposes of its functions. The notice will specify a period within which the required information must be furnished. The person on whom the requirement is made, may apply to the District Court within seven days, to vary, confirm or annul the order.
A person on whom the order is made and which is not varied on appeal, must furnish the requisite information.Information furnished must remain confidential. The information may be disclosed for the purpose of discharge of functions under the legislation, with consent or in certain legal proceedings for investigation.
There are a number of offences under the legislation. A person who contravenes statutory provisions is guilty of an offence. There are more general offences. Some offences may be prosecuted summarily or on indictment. District offences are subject to fine up to €5,000 or 12 months’ imprisonment or both. Persons convicted on indictment are liable to a fine up to €3,000,000 or imprisonment of up to two years or both.
The court may, unless there is substantial reason not to do so, order the person to pay, the HSA authority the costs occurred in prosecutions and investigations detections of the offence.
The Minister may make regulations providing for a so-called on-the-spot fines in respect of breaches of the legislation. A fine may provide for a payment of a penalty up to €2,000,000 or if the payment is made within the requisite period proceedings may be withdrawn.
Where an offence is committed by a company and it is proved to be done with the consent, connivance are is attributable to the neglect of any director, manager, secretary or officer, that person may also be guilty in his own right.
The HSA initiates and prosecutes summary offences. There is provision for appeal to the Circuit Court from certain District Court orders.