November 24, 2010 by Rhiannon Smith
Industry initiatives on nanomaterials
The Proposal for an EU reporting system for nanomaterials by the European Commission DG Environment from May 2010 suggested a need within the EU for mandatory reporting on nanomaterials. The report highlighted possible information gaps for nanomaterial properties under REACH, including:
- The current tonnage threshold;
- The limitations of current guidelines for the testing of nanomaterials;
- Communication issues with downstream users;
- Exemptions of nanomaterials under REACH; and
- Time-lags when registering lower tonnage substances.
It concluded that the REACH regulations are unlikely to provide the information needed to assess the potential risks from nanomaterials and recommended an additional reporting system for nanomaterials on the market at an EU level. The report proposed that nanomaterials should be considered as “new” substances, with a 2013 registration deadline, and that the threshold tonnage should be reduced to 10 kg for commercially available nanomaterials.
EU Member State initiatives on nanomaterials
In 2006, DEFRA ran a voluntary reporting scheme on nanomaterials in the UK, which had little response from industry.The Australian voluntary scheme ran much better, with a tiered approach starting with very general questions about tonnages, followed up with more in-depth analysis of the substances of interest.
There have been other initiatives across Europe, with Germany’s mandatory product inventory and Sweden’s enforcement of a zinc oxide UV-filter ban. In 2010, the Netherlands conducted a Legal Study on the possibility of introducing national regulations on nanotechnologies, Italy had a ministerial decree relating to the establishment of a national database on nanomaterials and the Belgian Presidencyproposed a nanomaterials register. The main French initiative is the ‘Grenelle de l’environnement’. Outside the EU, Norway proposed mandatory reporting andCanada, Australia, the US and the State of California have all been looking at nanomaterials regulation.
Le Grenelle de l’environnement
Le Grenelle de l’environnement includes a call for the anticipation of the risks linked to the production and use of manufactured nanomaterials, with no minimum tonnage threshold. It calls for a mandatory reporting of quantities and uses of nanomaterials and the supply of information to the public and consumers. The proposal requests increased information on the risks and protection measures for employees and recommends national public debate to improve traceability and risk assessment. The SCENHIR definition of nanomaterials is currently used, though this may change when the EU definition is released. The proposals are applicable to France, and there is uncertainty about nanomaterials in mixtures and the use of the phrase “under foreseeable conditions of use”.
Belgian Presidency Proposal
In September 2010, the Belgian Presidency of the EU proposed:
- A mandatory register of nanomaterials, allowing them to be traced up and down the product supply chain;
- The regulation of claims made on labels of products containing nanomaterials;
- The obligation to inform the consumer of the presence of nanomaterials in consumer products;
- The identification of the most appropriate regulatory path at EU level for risk evaluation and management; and
- Support for Member States to develop national strategies.
The September workshop run by the Presidency revealed a number of issues for nanomaterials, including a strong demand for transparency and information as well as the fact that national compulsory declarations measures may lead to a fragmented internal market. The outcome of the workshop led to calls for “harmonised, compulsory databases of nanomaterials and products containing nanomaterials” and to a request that the 2012 review of REACH should recommend the following:
- Lower the tonnage trigger for nanomaterials;
- Modify the data requirements for nanomaterials in REACH annexes;
- Review Annex V exemptions and Annex XIII on PBT and vPvB substances;
- Consider nanomaterials as new substances (e.g. requiring separate registrations); and
- Define nanomaterials and articles containing nanomaterials under REACH.
The applicability of national proposals under REACH
Member State national measures must be justified in cases where REACH does not harmonise the requirements for manufacture, placing on the market or use: “Member States shall not prohibit, restrict or impede the manufacturing, importing, placing on the market or use of a substance, on its own, in a preparation or in an article, falling within the scope of this Regulation, which complies with this Regulation and, where appropriate, with Community acts adopted in implementation of this Regulation”. However, REACH also states that: “Nothing in this Regulation shall prevent Member States from maintaining or laying down national rules to protect workers, human health and the environment applying in cases where this Regulation does not harmonise the requirements on manufacture, placing on the market or use”.
There are ongoing discussions whether REACH fully harmonises the conditions for manufacture, placing on the market and use of nanomaterials. If regulation under REACH is considered sufficient, this would prevent Member States from being able to impose their own national measures. Proposals to require reporting of nanomaterials or to impose registration, notification or reporting for nanomaterials or other substances manufactured or imported at less than 1 tonne per year could not legally be implemented if REACH was considered to fully harmonise and sufficiently regulate these areas. However, this would not prevent national measures on nanomaterials which would require a specific analysis, preparation of an Annex XV dossier for theauthorisation or restriction processes or take a provisional measure under the “safeguard” clause.
Provisional Measures under REACH
Member States are allowed to take appropriate provisional measures where they have “justifiable grounds for believing that urgent action is essential to protect human health or the environment in respect of a substance”, even if the substance is manufactured or imported at less than 1 tonne per year or satisfies the requirements of REACH. The Member State must immediately inform the Commission, giving “reasons for its decision and submitting scientific or technical information on which the provisional measure is based”, which the Commission then reviews. Provisional measures must be substance-specific, and precautionary and provisional within the existing legislation. These provisional measures can instigate a restriction procedure.
Provisional Measures under the Treaty for the Functioning of the European Union
Provisional measures under TFEU only allow Member States to introduce national provisions based on “new scientific evidence” relating to the protection of the environment or working environment, or on the grounds of a problem “specific to that Member State” arising after the adoption of the harmonised measure. The Member State is required to notify the Commission, which is then required to decide whether they are acceptable and to consider whether harmonised measures should be updated in the light of national provisions, in order to ensure the preservation of the internal market.
REACH is underpinned by the “precautionary principle“, which is used to interpret existing requirements but does not offer a separate avenue outside the existing regulations. According to Commission Guidelines (February 2000), the use of the precautionary principle requires:
- Identification of the degree of scientific uncertainty following scientific evaluation;
- Assessment of the potential consequences of inaction; and
- A transparent review of available management options (e.g. ban, restriction, labelling etc.).
Any measure taken on the basis of the precautionary principle must be proportionate, non-discriminatory and consistent and include socioeconomic impact and cost-benefit analyses. Precautionary principle measures must be temporary, pending a review of scientific developments.
Conclusions on Member State measures
Some lawyers have concluded that there is not a lot of scope for national measures on nanomaterials, as Member States can either subject a given nanomaterial to Authorisation or Restriction under REACH, or adopt a provisional measure. These are usually substance-specific and the burden of proof is on the Member State that the measure meets the conditions for each provision. However, there are arguments that national measures on nanomaterials would not be applicable, as the 2012 REACH Scope Review is expected to address nanomaterials.