Dara Calleary (Mayo, Fianna Fail)

I am pleased to bring before the Seanad the Chemicals (Amendment) Bill 2010. The main purpose of the Bill is to meet EU obligations to implement and enforce certain EU regulations. These include the EU regulation on the classification, labelling and packaging of substances and mixtures, known as the CLP regulation, a replacement EU regulation on the export and import of dangerous chemicals implementing the Rotterdam Convention, and periodic technical amendments to these two EU regulations and to the EU REACH and detergents regulations. The Bill also includes some minor technical changes to the Safety, Health and Welfare at Work Act 2005.

It is important to be clear that this Bill is not about transposing EU directives. It is about providing an enforcement of framework for EU regulations. The provisions of those EU regulations, with which this Bill is concerned, are directly applicable in Ireland. We must comply with their provisions. We cannot change them by implementing legislation. The provisions of the Bill therefore relate only to measures necessary for enforcement.

Before considering the provisions of the Bill, it is worth considering the background to these new EU regulations. First, the EU CLP regulation was introduced into EU law on 20 January 2009. This had its origin in the UN globally harmonised system of classification, labelling and packaging of chemicals It is useful to understand the aims of this United Nations system.

Some chemicals, from their production right through to their ultimate use, can be a danger to human health and the environment. All classes and ages of people can be confronted frequently with potentially dangerous products. Given the global trade in chemicals and the need to develop programmes to ensure their safe use, transport and disposal, it was recognised that an internationally harmonised system for classification and labelling would be desirable. Such an approach would facilitate the creation of national frameworks to control chemical exposures and protect people.

The globally harmonised system of classification and labelling of chemicals, otherwise known as GHS,was created to meet this need. GHS classifies chemicals by types of hazard. It generates harmonised templates for communicating hazards, including labels and safety data sheets. GHS seeks to ensure information on physical hazards and toxicity from chemicals is available in order to enhance the protection of human health and the environment during the handling, transport and use of these chemicals. The GHS also provides a basis for harmonising rules and regulations on chemicals at national, regional and worldwide level, an important factor for trade facilitation.

The EU CLP regulation is the EU's expression of that global system. As with the global system, the main aims of the CLP regulation are to help protect human health and the environment by determining which properties of substances and mixtures lead to classification as hazardous and by correctly identifying and communicating hazards. The changeover to the new rules will be phased and will fully replace the existing body of EU law in this area from June 2015.

The first notable change will be the requirement on manufacturers and importers to reclassify their substances from 1 December this year. All substances placed on the market on or after 1 December will be required to be notified to the European Chemicals Agency within one month. I am informed that the European Chemicals Agency's feedback from industry predicts that the number of notifications could be 2 million or even more. Up to yesterday, the number already notified was 820,337.

It is very important for our industry to meet the CLP notification deadline. I reiterate that this means substances on the market on 1 December will have to be reclassified and notified to the European Chemicals Agency by 3 January 2011.

The European Chemicals Agency will maintain an inventory of all notified classifications. This inventory is one of the cornerstones of the CLP regulation. As well as the potential health and environmental benefits of the inventory, there should also be business benefits through improved trade flows throughout the European Union. The Health and Safety Authority has a dedicated help desk to provide information and assistance for manufacturers and importers in meeting their obligations.

It is worth noting the CLP regulation was intended to be incorporated in the enforcement framework of the Chemicals Act 2008, in line with the policy decision to streamline the regulatory framework for enforcement of certain European Union chemicals legislation. It was included within the scope of the regulatory impact assessment which was carried out in the context of the Chemicals Bill 2007. The public consultation undertaken at the time was positive on the inclusion of these EU regulations within the scope of the Chemicals Act. As the CLP regulation had not been adopted at EU level before the passing of the Chemicals Act 2008, it was not possible to include it within the scope of the Act. A further regulatory impact assessment was carried out in the context of the Chemicals (Amendment) Bill 2010. As the policy approach to the enforcement of such EU chemicals legislation has not changed in the meantime, the outcome of the 2007 consultation remains relevant.

The inclusion of the CLP regulation does not impose additional compliance costs on industry. The impact of the regulation was examined both at European Union and national level and by the then Joint Committee on Enterprise, Trade and Employment.

The second new European Union regulation concerns the export and import of dangerous chemicals. It replaces an EU regulation from 2003 and implements in the Union the Rotterdam Convention on prior informed consent. The aims of the convention are to promote shared responsibility and co-operative efforts in the international trade of certain hazardous chemicals, contribute to the environmentally sound use of these hazardous chemicals by facilitating information exchange on their characteristics and provide for a national decision making process on their import and export. The convention covers pesticides and industrial chemicals which have been banned or severely restricted for health or environmental reasons by parties to the convention. In the context of the EU regulation, this means dangerous chemicals and pesticides listed in the annexes may only be exported with the prior consent of the importer in the importing country. In addition to provisions relating to chemicals and pesticides 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 EU legislation.

I will now outline the provisions of the Bill. The legislation, as published, was subject to one amendment by Dáil Éireann in section 4. Section 1 is a standard section and defines references to the "Principal Act" as meaning the Chemicals Act 2008. Section 2 contains technical amendments to definitions in section 2 of the principal Act. These changes reflect the new European Union regulations being brought within the enforcement framework of the Act.

Section 3 clarifies the regulation making powers of the Minister in section 5 of the principal Act in relation to classification, labelling and packaging of chemicals. It permits the Minister's power to amend the Act, by regulation, for the purpose of giving effect to a European Union Act relating to chemicals. This is an important amendment as it will mean there will not be unnecessary recourse to primary legislation for the purposes of implementing changes to EU Acts within the enforcement scope of the Chemicals Act. In considering this section it is also important to note that section 36 of the principal Act provides that all regulations made under the Act must be laid by the Minister before each House of the Oireachtas.

Section 4 amends section 8 of the principal Act by providing for the competent authorities for the purposes of the CLP regulation, namely, the Health and Safety Authority, the Minister for Agriculture, Fisheries and Food in respect of pesticides and Beaumont Hospital Board in respect of receiving information relating to emergency health response, and by substituting Beaumont Hospital Board for the Minister for Health and Children as the competent authority for the purposes of receiving information relating to emergency health response under the detergents regulation.

The amendment to the published Bill by Dáil Éireann concerned the substitution of Beaumont Hospital Board for the Minister for Health and Children as a competent authority for certain tasks under the CLP regulation and the detergents regulation. These allocations of responsibility reflect the existing divisions of responsibility.

Section 5 amends section 9 of the principal Act to ensure co-operation arrangements apply also to competent authorities for the CLP regulation. Co-operation between competent authorities is a very important feature of the legislation.

The IDA has highlighted the extent to which the pharmachem industry in general is regulated. In its recent report, Making it Happen — Growing Enterprise for Ireland, Forfás identifies regulation as one of the key elements to the mix that should provide a supportive business environment for business to grow. The degree of regulatory compliance is one of the key measures in determining the competitiveness of an economy. The Chemicals (Amendment) Bill 2010 is designed to achieve such a positive regulatory environment for business. Putting in place such co-operation arrangements should contribute to a clear regulatory framework for business and allow us to make optimum use of resources, avoiding unnecessary costs for both the competent authorities and industry.

Sections 6 and 7 amend sections 14 and 15, respectively, of the principal Act. The amendment seeks to rectify weaknesses in the provisions of the Act which deal with improvement notices. This came to light as a result of a High Court ruling on similar provisions of the Safety, Health and Welfare at Work Act 2005. The Bill makes it clear that an improvement plan or a revised improvement plan prepared by an operator and submitted to an inspector must be adequate in the view of the inspector and must be implemented by the operator. It is important to rectify this matter if the section is to retain its usefulness and avoid the need for competent authorities to use more stringent enforcement powers. A similar amendment to the Safety, Health and Welfare at Work Act 2005 is included in the technical amendments under section 12.

Section 8 amends section 16 of the principal Act to make it clear that the power to issue prohibition notices applies in relation to enforcing European Union rules for the control of major accident hazards relating to dangerous substances. Section 9 amends section 29 of the principal Act to create offences for breaches of the CLP regulation and allow the penalties under section 30 to apply. Section 10 amends section 30 of the principal Act to increase the maximum custodial sentence on summary conviction from six months to 12 following the advice of the Attorney General.

Section 11 has the effect of including within the enforcement framework of the Chemicals Act purely technical amendments to the four EU regulations within the scope of the Act, as amended, namely, REACH, CLP, detergents and Rotterdam. This will keep the regulatory framework simple, avoid gaps in the legal basis for enforcement activities and avoid unnecessary demands on resources normally required in the preparation of regulations.

Section 12 makes technical amendments to the Safety, Health and Welfare at Work Act 2005, including completing the transposition of Directive 91/383/EEC supplementing the measures to encourage improvements in the safety and health at work of workers with a fixed duration employment relationship or a temporary employment relationship of 25 June 1991; clarifying the position on ministerial obligations to consult in the making of certain regulations; clarifying the provisions relating to improvement plans and revised improvement plans, as I indicated; and increasing the maximum penalties on conviction for summary offences from a fine of €3,000 and-or six months imprisonment to a fine of €5,000 and-or 12 months imprisonment.

Section 13 is a standard section, providing for the Short Title of the Bill, collective citations and commencement.