Billy Kelleher (Cork North Central, Fianna Fail)

I am pleased to bring before this House the Chemicals Bill 2008. The Bill has passed all stages in the Dáil and reflects amendments based on some important issues raised by Opposition parties. I will highlight these in going through the Bill.

The main purpose of the legislation is to facilitate the enforcement of certain EU regulations concerning chemicals. These EU regulations include the REACH regulation, REACH being the acronym for the registration, evaluation, authorisation and restriction of chemicals, the regulation concerning the export and import of certain dangerous chemicals under the Rotterdam Convention, and the detergents regulation.

The Bill also provides the means for giving effect to EU directives concerning the control of major accident hazards involving dangerous substances. The Bill does not apply to waste, human or veterinary medicines, food flavourings or feedstuffs, all of which will continue to be regulated under existing legislation.

The provisions of the three EU regulations with which this Bill is concerned are directly applicable in Ireland. That means their provisions must be complied with and cannot be changed by any implementing legislation. Therefore, the provisions of the Bill relate only to measures necessary for enforcement.

Chemicals are critical to the way we live today. They form part of virtually everything we make and use and provide enormous benefits to society. Some chemicals, however, can present risks to human health and the environment. They may cause damage if, for instance, they are toxic or carcinogenic, or they may give rise to major accidents if not properly controlled. For that reason, it is important to have systems in place to identify, monitor and control chemicals and their effects while continuing to ensure they are available for the benefit of society.

I will summarise the background and context for the Bill, outline briefly the approach taken in framing it and then describe the purpose and reasoning behind each section. The best known of the EU regulations being given further effect to by this Bill is the EU REACH regulation. This entered into force on 1 June 2007, giving a legal basis to the new European Chemicals Agency. Most of the provisions of the REACH regulation entered into force on 1 June 2008 and the enactment of this Bill will ensure the necessary enforcement measures are in place without undue delay. Under REACH, the burden of proof lies with industry. All manufacturers and importers of chemicals must identify and manage risks linked to the chemicals they manufacture and market. For chemicals produced or imported in quantities of 1 tonne or more per year per enterprise, manufacturers and importers need to demonstrate they have done so by means of registering the chemicals with the European Chemicals Agency.

It is estimated that about 30,000 chemicals in use will have to be registered with the European Chemicals Agency. The full registration will take place over a period of ten years from now, starting with chemicals with the greatest risk and finishing with those with the least risk. However, all these chemicals are subject to pre-registration at the European Chemicals Agency over a six-month period which began on 1 June 2008. That means all manufacturers and importers of chemicals will have to pre-register chemicals by 1 December 2008. The European Chemicals Agency is expecting 130,000 pre-registrations over the six-month period. During the first two weeks of pre-registration, the agency reported 7,360 pre-registrations. It may then check that each chemical complies with the regulation and must evaluate testing proposals submitted by the registrant to ensure the assessment of the chemical substances will not result in unnecessary testing, especially on animals.

REACH also provides for an authorisation system aimed at ensuring substances of very high concern are properly controlled and progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. Where this is not possible, the use of substances may only be authorised where there is an overall benefit to society from using the substance. In addition, REACH provides for the imposition of restrictions on the manufacture, use or placing on the market of substances causing an unacceptable risk to human health or the environment. That is a feature of existing EU legislation. REACH is probably the most ambitious chemicals legislation in the world. It should enable us to significantly increase our knowledge on the use of chemicals and on how to use them safely.

The EU regulation on the export and import of dangerous chemical implements in the EU is the Rotterdam Convention on prior informed consent. A dangerous chemical that is listed in the annexes of the EU regulation may only be exported with the prior consent of the importer in the importing country. In addition to provisions relating to chemicals listed in the annexes, the regulation also contains provisions that apply to all chemicals when exported. These provisions address, in particular, requirements on packaging and labelling as specified by respective Community legislation. The objective of the procedure under the regulation is to protect human health and the environment from potential harm and to contribute to the environmentally sound use of such chemicals.

The detergents regulation entered into force on 8 October 2005, replacing five directives concerning the biodegradability of surfactants, which are chemicals used in detergents to give them the ability to remove dirt, but that can have adverse effects on the environment. The scope of the regulation is to harmonise rules relating to the biodegradability of surfactants in detergents, restrictions or bans on surfactants on grounds of biodegradability, additional labelling of detergents, including fragrance allergens, and information that manufacturers must hold at the disposal of the member states' competent authorities and medical personnel. The key aims of the regulation are to safeguard the Single Market in these products and to ensure a high level of environmental protection.

The approach in framing the Chemicals Bill was to provide a clear regulatory framework for business that would result in high levels of compliance and increased co-operation between the various national authorities in order to maximise efficiencies in enforcement. The draft heads of the Bill were the subject of public consultation in October and November 2007, and a regulatory impact assessment was carried out on a number of enforcement options. The analysis in the regulatory impact assessment concluded that the principal benefits of the Chemicals Bill should be high levels of compliance; reduced administrative costs to business; increased co-operation between the various national authorities that will be involved in enforcement, and a coherent legal framework, which is an important factor for industry, and that would also further the better regulation agenda.

By taking the approach of putting all enforcement measures in one Bill, the Chemicals Bill should put in place a more streamlined and coherent legal framework for the regulation of chemicals in Ireland. For example, the detergents regulation, which is currently given further effect by statutory instrument, has been brought within the scope of the Bill to streamline and make more effective the national enforcement arrangements. In addition, existing regulations apply to the control of major accident hazards made under the European Communities Act. Remaking those regulations under the Bill when enacted will further streamline the approach to legislating for chemicals.

Section 1 is a standard section, providing for the short title of the Bill and the commencement on enactment of ministerial order of its various provisions. Section 2 is a standard interpretation provision. The Bill, the directly applicable EU regulations and any regulations that may be made under section 5 are collectively described as the relevant chemicals statutory provisions. Section 3 is a standard section and provides for the methods of serving notices under the Bill. Section 4 is a standard provision, providing for Exchequer funding of administrative expenses. Section 5 enables the Minister for Enterprise, Trade and Employment to make regulations under the Bill. EU regulations, as Senators are aware, are directly applicable but it can be necessary to make national regulations containing supplementary or incidental provisions. The Minister for Enterprise, Trade and Employment may also, with the consent of each of the named Ministers with a specific functional responsibility, make regulations giving effect to an Act adopted by an institution of the European Communities relating to chemicals, including the control of major accident hazards relating to chemicals. Currently regulations under the European Communities Act govern this area. The provision in the Bill to make replacement regulations should result in a clearer legal framework.

Section 6 provides that the Health and Safety Authority can review legislation at the behest of the Minister or on its own initiative and make proposals to the Minister as appropriate. Before it does so, it will be required to consult other parties as appropriate. That is similar to provisions in the Safety, Health and Welfare at Work Act 2005. The chemicals area is complex and clear guidance is required to help industry comply with the relevant statutory frameworks. Accordingly, section 7 provides for national codes of practice to be drawn up by the Health and Safety Authority setting out practical guidance as regards compliance. Section 8 prescribes the national authorities for the purposes of the EU regulations. Six different national authorities are named, spanning the functional responsibility areas of five different Departments. The Health and Safety Authority is given functions under all three EU regulations. The Minister for Agriculture, Fisheries and Food is given functions relating to pesticides under the two relevant EU regulations. The Environmental Protection Agency is given functions under the REACH regulation in respect of the prevention of environmental pollution and under the detergents regulation in respect of matters relating to biodegradability of surfactants in detergents. The Minister for Health and Children is given a function under the detergents regulation relating to information on chemicals necessary for medical purposes. The Irish National Accreditation Board is given a function to approve laboratories under the detergents regulation. Last but not least, the Revenue Commissioners are given a function for controlling exports and imports under the export-import regulation. The nomination of the range of national authorities under the Bill reflects the horizontal nature of chemicals policy, ensures that the relevant expertise from across the whole system is part of the enforcement framework, and reflects the policy choice of creating an enforcement network using existing structures.

Section 9 provides for co-operation among the national authorities in regard to their functions under the Bill. The purpose of the provision is to encourage and facilitate optimal efficiency and effectiveness by national authorities in carrying out their functions under the Bill. The section also allows national authorities to make mutual co-operation arrangements with relevant authorities in other EU and EEA member states. Section 10 allows a national authority, subject to the approval of the Minister and the Minister for Finance, to charge appropriate fees in regard to the performance of its functions or the provision, by that national authority, of services.

Section 11 provides for the appointment of inspectors for the enforcement of the relevant statutory provisions and section 12 sets out their general powers. Section 13 provides for the immunity and indemnity of inspectors or members of staff of a national authority. Section 14 allows an inspector to issue a direction for an improvement plan if he or she is of the opinion that an activity is being carried out that involves a risk to human health or the environment. Section 15 allows an inspector to issue a person with a contravention notice where the inspector is of the opinion that the person concerned is contravening the relevant chemicals statutory provisions. That could include the removal from the market of a chemical. Section 16 provides that an inspector may issue a prohibition notice if he or she is of the opinion that an activity is occurring that represents a serious risk to human health or the environment. Section 17 allows an inspector to apply to the High Court for an order to enforce compliance with a prohibition notice. Section 18 provides that a national authority may direct any of its staff or another appropriate person, that is, other than an inspector, to carry out an investigation and make a report of that investigation. Section 19 applies where a national authority considers that an activity contravening the relevant chemicals statutory provisions is a serious risk to human health or the environment. In such a case, the section provides that the national authority may apply to the High Court for an order prohibiting that activity. Sections 20 and 22 effectively enable officers of Customs and Excise to act in the general enforcement of statutory provisions governing chemicals and also to take action at the specific request of a national authority.

Section 21 relates to evidence in proceedings and was introduced by Government amendment on Committee Stage in the Dáil. It allows for documentary evidence to prove what is stated and means that any documents generated by a company and any documents required under the EU regulations to be generated or kept can be used as evidence, subject to certain restrictions, including legal privilege. Section 23 allows a national authority, in the interests of the protection of human health or the environment, to make public information on matters giving rise to the issuing of contravention notices or prohibition notices.

Section 24 obliges the Health and Safety Authority to publish a list of persons convicted of an offence under the relevant chemicals statutory provisions and a list of persons in respect of whom an order has been made under section 17 or section 19, and allows publication of names of persons on whom prohibition notices have been served. That is partly a name-and-shame provision that should have a deterrent effect on would-be offenders. The obligatory part of the section was introduced by Government amendment on Report Stage in the Dáil, on foot of a Committee Stage Opposition amendment.

Sections 25 and 26 are provisions to protect whistleblowers. Section 25 is a more general provision, and Section 26, which was introduced by Government amendment on Report Stage in the Dáil, on foot of a Committee Stage Opposition amendment, is more specifically focused on employees. Section 27 provides that national authorities may, by serving a notice, require persons to give relevant information to that national authority and section 28 prohibits the unauthorised disclosure of confidential information. Section 29 sets out the offences under the Bill and section 30 sets out the penalties for offences committed under section 28. The maximum penalty on summary conviction is a fine not exceeding €5,000 or six months imprisonment, or both. For certain summary offences the penalty of imprisonment does not apply. The maximum penalty on indictment is €3 million or imprisonment for a term not exceeding two years, or both.

Section 31 provides that the Minister may make regulations allowing inspectors to serve fixed payment notices in amounts up to a maximum of €2,000 to persons who have committed an offence. The regulations may set out different amounts for different offences. Section 32 provides that where an offence under the Act is committed by a body corporate and that the act which gave rise to the offence is proved to have been authorised by or as a result of an omission by a director or manager of the body corporate, both the person and the body corporate are liable to be prosecuted. Section 33 is a standard section and provides that a national authority may prosecute summary offences under the Act.

Section 34, which was introduced by Government amendment on Committee Stage in the Dáil, makes it clear that there is a right of appeal from the District Court to the Circuit Court by either side from a decision of the District Court to confirm, vary or cancel a notice issued by a national authority. Section 35 sets out that notices or directions made under the Act shall be in writing. Section 36 provides for regulations or orders to be laid before the Houses of the Oireachtas. Section 37 sets out two technical amendments to the Safety, Health and Welfare at Work Act 2005.

The Chemicals Bill sets out an enforcement system. It aims to provide a clear regulatory framework for business in order to ensure high levels of compliance. It also aims to achieve increased co-operation between the various national authorities that will be involved in enforcement in order to optimise the use of State resources and to alleviate any unnecessary administrative costs to business. Compliance with the new chemicals regime by business should result in better management of the risks associated with the use of chemicals and therefore a positive longer-term health and environmental impact. By taking the approach of putting all enforcement measures in one Bill, the Chemicals Bill should put in place a more streamlined and coherent legal framework for the regulation of chemicals in Ireland.

On Committee and Report Stages in the Dáil, we took a consensual approach to the Bill. We accepted a number of amendments from the Opposition. There were no divisions in the House and we had a very positive debate. This legislation when enacted will streamline and assist businesses. Most importantly it will allow us to gather information in order to assess whether, and ensure that, the chemicals being used do not have a harmful effect either on human health or on the environment. As time evolves it will give us the enforcement powers to address breaches in the Act. It is very progressive legislation that represents the enforcement side of the REACH regulation, which is already in place and to which companies are obliged to adhere. I commend the Bill to the House and look forward to this Second Stage debate.