ZINC OXIDE PRODUCERS ASSOCIATION
Regulations
Get to know all about Zinc Oxide Directives and Regulations
REACH
REACH is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.
In principle, REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances. Therefore, the regulation has an impact on most companies across the EU.
REACH places the burden of proof on companies. To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They have to demonstrate to ECHA how the substance can be safely used, and they must communicate the risk management measures to the users.
For details and more complete information on REACH , please go to echa.europa.eu
For more information on zinc oxide compliance in REACH and specific information, please go to www.reach-zinc.eu
CLP (GHS)
Before placing chemicals on the market, the industry must establish the potential risks to human health and the environment of such substances and mixtures, classifying them in line with the identified hazards. The hazardous chemicals also have to be labelled according to a standardised system so that workers and consumers know about their effects before they handle them.
Thanks to this process, the hazards of chemicals are communicated through standard statements and pictograms on labels and safety data sheets.
CLP stands for Classification, Labelling and Packaging. The CLP Regulation entered into force in January 2009, and the method of classifying and labelling chemicals it introduced is based on the United Nations’ Globally Harmonised System (GHS).
The Regulation replaces over time two previous pieces of legislation, the Dangerous Substances Directive and the Dangerous Preparations Directive. There is a transition period until 2015.
For more information on chemicals, please go to ECHA – European Chemicals Agency
Food contact
- Packaging materials;
- Cutlery and dishes;
- Processing machines;
- Containers;
- Materials and articles in contact with water for human consumption.
The term does not cover fixed public or private water supply equipment.
Principles for EU legislation
Harmonising legislation on food contact materials at EU level aims to:
- Protect consumers’ health;
- Remove technical barriers to trade.
Safety and migration of food contact materials
Food contact materials must not transfer their components into the foods in unacceptable quantities (migration).
Migration limits for plastic materials:
- Overall Migration Limit – 10mg of substances/dm² of the food contact surface for all substances that can migrate from food contact materials to foods;
- Specific Migration Limit (SML) for individual authorised substances fixed on the basis of a toxicological evaluation.
SML is set according to the Acceptable Daily Intake or the Tolerable Daily Intake established by the Scientific Committee on Food.
The limit is set on the assumption that every day throughout lifetime, a person weighing 60kg eats 1kg of food packed in plastics containing the substance in the maximum permitted quantity.
Cosmetics Directive
Legislation
Council Directive 76/768 of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (“Cosmetics Directive”) has been adopted in 1976 in order to ensure the free circulation of cosmetic products in the internal market and to ensure the safety of cosmetic products placed on it.
Since its adoption, the Cosmetics Directive has been amended by the European legislators (the European Parliament and the Council) seven times in order to reflect new trends and challenges concerning cosmetic products. For example, the “sixth amendment” led to the adoption of the inventory of ingredients used in cosmetic products and introduced the principle of marketing ban in relation to tests on animals. The “seventh amendment” provided inter alia for more detailed provisions notably on the phasing out of animal testing.
Apart from these so-called ‘amendments’, the Commission has adopted more than fifty ‘adaptations’ in order to adapt to technical process the provisions in the annexes to the Cosmetics Directive to technical progress.
In order to provide guidance to Member State authorities, industry, and other stakeholders on the interpretation of various provisions of the Cosmetics Directive, a number of guidance documents, have been adopted in close cooperation with the Member State authorities.
Revision of the Cosmetics Directive
The Cosmetics Directive has been recasted into a Regulation. On 30 November 2009, was adopted the new Cosmetic Products Regulation, EU Regulation 1223/2009.
With the new Cosmetics Regulation Europe is having a robust, internationally recognised regime, which reinforces product safety taking into consideration the latest technological developments, including the possible use of nanomaterials.
Most of the provisions of this new regulation will be applicable as from 11 July 2013. The ban and the strict regime aiming at phasing out animal testing were not modified.
Transportation
Useful links:
ADR page: http://www.unece.org/trans/danger/publi/adr/adr_e.html
Transport of goods needs to be regulated in order to prevent, as far as possible, accidents to persons or property and damage to the environment, the means of transport employed or to other goods. However, with different regulations in every country and for different modes of transport, international trade in chemicals and dangerous products would be seriously impeded, if not made impossible and unsafe. Moreover, dangerous goods are also subject to other kinds of regulations, e.g. work safety regulations, consumer protection regulations, storage regulations, environment protection regulations.
In order to ensure consistency between all these regulatory systems, the United Nations has developed mechanisms for the harmonization of hazard classification criteria and hazard communication tools (GHS) as well as for transport conditions for all modes for transport (TDG). In addition, the UNECE administers regional agreements that ensure the effective implementation of these mechanisms as far as transport of dangerous goods by road, rail and inland waterways is concerned.
Maritime transportation:
IMO page: http://www.imo.org/
IMDG page: http://www5.imo.org/SharePoint/mainframe.asp?topic_id=158
Aviation:
IATA page: http://www.iata.org
Download the Guidance on transportation of zinc oxide and zinc powder
UP_2012-07-04_12-39-20_zinc_transport_fact_sheet_final
Water framework Directive
ACT
Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy
SUMMARY
The European Union (EC) has established a framework for the protection of:
- inland surface waters;
- groundwater;
- transitional waters and
- and coastal waters
This Framework-Directive has a number of objectives, such as preventing and reducing pollution, promoting sustainable water usage, environmental protection, improving aquatic ecosystems and mitigating the effects of floods and droughts. Its ultimate objective is to achieve “good ecological and chemical status” for all Community waters by 2015.
Administrative arrangements
Member States have to identify all the river basins lying within their national territory and to assign them to individual river basin districts. River basins covering the territory of more than one Member State will be assigned to an international river basin district.
Member States are to designate a competent authority for the application of the rules provided for in this Framework-Directive within each river basin district.
Identification and analysis of waters
By 2004 at the latest, each Member State had to produce:
- an analysis of the characteristics of each river basin district;
- a review of the impact of human activity on water;
- an economic analysis of water use;
- a register of areas requiring special protection;
- a survey of all bodies of water used for abstracting water for human consumption and producing more than 10 m³ per day or serving more than 50 persons.
This analysis must be revised in 2013 and every six years thereafter.
Management plans and programmes of measures
In 2009, nine years after the Framework-Directive entered into force, management plans were produced for each river basin district, taking account of the results of the analyses and studies carried out. These plans cover the period 2009-2015. They shall be revised in 2015 and then every six years thereafter.
The management plans must be implemented in 2012. They aim to:
- prevent deterioration, enhance and restore bodies of surface water, achieve good chemical and ecological status of such water by 2015 and to reduce pollution from discharges and emissions of hazardous substances;
- protect, enhance and restore the status of all bodies of groundwater, prevent the pollution and deterioration of groundwater, and ensure a balance between groundwater abstraction and replenishment;
- preserve protected areas.
Member States shall encourage participation by all stakeholders in the implementation of this Framework-Directive, specifically with regard to the management plans for river basin districts. Projects from the management plans must be submitted to public consultation for at least 6 months.
Member States must introduce arrangements to ensure that effective, proportionate and dissuasive penalties are imposed in the event of breaches of the provisions of this Framework Directive.
A list of priority substances selected from among the ones which present a significant risk to the aquatic environment has been drawn up at European level. This list is set out in Annex X to this Framework-Directive. Zinc is not in this priority list.