Reaction to chemicals20 May 2019
The following is an edited extract from the report ‘ECHA Strategic Plan 2019-2023’ from the European Chemicals Agency.
The European Chemicals Agency (ECHA) is an EU body established on 1 June 2007 by regulation number 1907/2006 concerning the registration, evaluation, authorisation and restriction of chemicals (REACH). Its mandate is to manage and carry out technical, scientific and administrative aspects of REACH. ECHA was also established to manage tasks related to the classification and labelling of chemical substances, which, since 2009, has been governed by regulation number 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP). In 2018, ECHA was allocated a specific task concerning substances in articles under directive 2018/851 on waste. Or, to put the mission more simply, along with its partners, ECHA works for the safe use of chemicals.
The EU has an extensive system of legislation controlling chemicals. REACH, CLP, biocidal products regulation (BPR), PIC (export and import of hazardous chemicals) and the specific task under the water frameworks directive (WFD) all form an integral part of this system.
Excluding pharmaceuticals and veterinary products, the system starts with the basic regulation REACH on industrial chemicals, the regulation on plant-protection products and BPR on biocides. It lays out the marketing and use conditions for these three types of chemicals. The regulations have similar approaches – before a chemical is allowed on the market or to be used, information on its hazards and uses must be generated. Authorities assess the information before granting market access (or not). This assessment is in-depth within an authorisation system for plant protection products, biocides and certain industrial chemicals, and a screening level for all other industrial chemicals. The regulations have clear interfaces – all active plant-protection and biocidal ingredients are automatically registered under REACH.
Reaching across these three basic regulations, the CLP regulation (classification and labelling of chemicals), sets out rules on how to classify, package and label the industrial chemicals, plant-protection products and biocides. The application of the CLP rules forms an integral part of the authorities' decision for market access for all three types of chemicals. Furthermore, product-specific regulations covering, for example, cosmetics, toys, food contact materials, detergents or electronic equipment, form a second layer of legislation setting particular conditions for chemicals in those products. Finally, there are regulations and directives involving chemicals, for example concerning the import and export of certain hazardous chemicals, chemical accidents, water, workers, eco-labelling, fertilisers, industrial emissions, or waste, which add conditions on the manufacture, marketing and use of chemicals.
The second and third layers of EU legislation do not require the generation of hazard information. They generally rely on REACH for the hazard information, always rely on CLP to determine hazards and often rely on REACH for risk management. REACH therefore interfaces with most of the EU’s chemicals legislation, whereas most chemicals legislation depends on the CLP classification.
During the time period 2019–23, the EU will take significant decisions and agree on key aspects of its overall future political direction.
In line with the conclusions of the evaluation of REACH, ECHA expects the political discussion and the results of the other assessments to conclude that the overall EU regulatory system for chemical safety must increase efficiencies in the current work, increase integration, improve consistency of the EU regulatory system and also improve transparency. The agency supports this view, shares the findings of the evaluation and consequently sees the need to focus on compliance of dossiers with direct effect on ECHA’s priority areas of work in the years to come.
Furthermore, the UK will leave the EU in 2019 (with no clarity currently on the future relations between the EU and the UK or on any possible transitional agreement).
Parallel to these political processes, ECHA has to find a sustainable balance between its regulatory role, transparency, stakeholder engagement and its independence. In this area, the public trust in EU institutions and agencies, and in evidence-based decision making, is at stake, which creates high demands for ECHA in its communication towards and engagement with the stakeholders and public.
ECHA will need to proactively and regularly adapt to these challenges, along with any new challanges. The union-wide discussions on the new multiannual financial framework (MFF), running from 2021–27, will set the human and financial framework for ECHA to implement its current mandate and meet these challenges.
Looking at ECHA’s activities, 2019 is a new era in chemical management, marking the final REACH registration deadline and the beginning of a uniform EU system for market access for chemicals. In the biocides field, the 2019–23 time period marks the final years leading to the 2024 deadline for the finalisation of the review programme for active substances. All biocides on the market will then be subject to one uniform EU system.
Currently, ECHA manages the implementation of the following legislation.
REACH requires companies to ensure that substances manufactured or imported above 1t per year are used safely. Companies must collect or generate specified chemical safety information, use this information to develop and apply safe use instructions, and communicate these instructions to users of the substances. Finally, to gain EU market access, they must document this in a registration dossier and submit it to ECHA. In order to promote the harmonised interpretation of data, and to reduce registration costs and testing on animals, registrants of the same substance have to share their data and submit their registration jointly. ECHA, working with the member state’s competent authorities, evaluates if the safety information collected by the industry is sufficient and, if not, requires additional information.
All companies – manufacturing, importing or using substances even below 1t – must assess their substances against the CLP classification criteria using all available chemical safety information and package the chemical, labelling the package accordingly. This obligation ensures that safety information, such as ‘causes serious eye irritation’ or ‘keep out of reach of children’, is available to workers and consumers. The company must submit the classification to ECHA’s publicly available classification and labelling inventory.
Under CLP, a member state can propose to harmonise the classification and labelling where this is need, and this is also obligatory for plant-protection products and biocides. Similarly under REACH, a member state, ECHA on request of the European Commission, or ECHA on its own initiative, can all propose restrictions, like a ban or a restriction on the use of a substance, if they find that there are risks that need to be addressed on a union-wide basis. ECHA assesses the scientific and technical aspects of the proposal, and based on this, the European Commission, together with the member states, takes the final decision.
REACH authorisation checks that substances of very high concern are used safely and are progressively replaced by suitable alternatives. Substances of very high concern are subject to authorisation when the European Commission and the member states include them in the authorisation list, based on a proposal from ECHA. These substances cannot be placed on the market for use after a given date, unless an authorisation is granted for the specific use. ECHA assesses the scientific and technical aspects of the authorisation application and, based on this, the European Commission, together with the member states, takes the final decision.
The BPR establishes an authorisation system for the placing on the market and use of biocidal products. ECHA coordinates the member states’ evaluation of active substances and the union-wide authorisation of biocidal products containing approved active substances. ECHA assesses the scientific and technical aspects of active substance approvals and union authorisation applications; based on this assessment, the European Commission, together with the member states, approves or refuses the active substance or the EU authorisation. ECHA is also the central hub for all national authorisation applications, establishment of technical equivalence, assessments of applications for alternative suppliers and resolution of data sharing disputes.
PIC implements the UN Rotterdam Convention in the EU. It applies to banned or severely restricted chemicals within the EU, and provides for information exchange mechanisms regarding the export outside and import inside of the EU of those chemicals. PIC thereby contributes to the global efforts on chemical safety.
Under the WFD, ECHA must develop and operate a database, which tracks the presence of substances of very high concern in articles throughout the supply chain.
In addition to this, for all legislation, ECHA disseminates information, prepares guidance, develops tailored IT systems and promotes harmonised enforcement actions by member states.
The European Commission’s evaluation of REACH concluded that it is effective, but not efficient, and its implementation is lagging behind in meeting its political objectives. Indeed, there are gaps and severe shortcomings in the chemical safety information submitted by the industry, especially with regards to long-term effects on human health and the environment, and in relation to the uses and exposure. ECHA’s assessment of the past and current situation on the level of compliance in registration dossiers with information requirements has been, and is in line with, the findings of the evaluation by the European Commission indicating the absolute need for action. Also, the industries knowledge on substances in articles needs to improve, not only to meet REACH obligations, but also to face the challenges coming from the EU’s objectives on fostering a circular economy. Improvement and simplification are also needed in relation to the extended safety data sheets, evaluation, authorisation and restrictions. The issues requiring the most urgent action are acceleration of evaluation, simplification of the application for authorisation processes, ensuring a level playing field with non-EU companies through effective restrictions and enforcement, and clarifying the interface of REACH and other EU legislation, in particular the legislation on occupational safety and health, and on waste.
Consequently, the activities of ECHA, the member states and the European Commission implementing REACH and CLP will need, on all fronts, to be accelerated. The evaluation activity must continue at higher intensity for longer than planned, and harmonised classification, labelling, restrictions and authorisation activities must accelerate. Registration activities will no longer have big peaks, but as of 2018, all substances above 1t are in REACH, so there will be a larger steady stream of updates and new registrations than before. Total resources will therefore need to be maintained, rather than decreased, during the next multiannual financial framework.
In line with sustained efforts needed for the REACH processes, and to meet the political objectives of BPR, ECHA will need to work with the member states to increase efficiencies. Biocides activities must intensify, using the accumulation of experience and competences to ensure that, by 2024, only fit-for-purpose biocidal active substances remain on the EU market. This provides the basis for the authorisation of all biocidal products by the member states and the European Commission.
For PIC, a high level of efficiency has been achieved already. The expected continued increase in the number of PIC notifications will test this capacity to handle PIC processes even more efficiently. Given the global perspective of PIC, its implementation by the agency makes international trade in hazardous chemicals more transparent, allowing countries to control the import of unwanted chemicals or by giving access to safety information if the import is accepted.
A further insight
Mikko Väänänen, press officer at ECHA, gives a little more information on the detail of the report and its effects on packaging.
When it comes to consumer goods and hazardous chemicals, the main thing to remember is that, within the EU, consumer chemicals have exactly the same classification, labelling and packaging requirements as do the professional chemicals. The legal requirements are all outlined in the CLP regulation.
The packaging requirements under CLP have not changed recently, and are not foreseen to do so in the near future. The only new development within the past five years that has been related to packaging was the provision on the requirements for the durability properties of soluble packaging for unit-dose laundry detergent capsules.
As to the supply chain, in terms of legal obligations, the responsibilities under CLP are defined in the legal text. Every supplier has the obligation to ensure that the labelling and packaging of a chemical complies with CLP. Distributors (retailers) are also suppliers. Distributors can rely on the classification derived by an actor up the supply chain. This means that a distributor is still responsible for ensuring that the chemicals they sell are labelled and packaged as is appropriate for a chemical that has been classified as indicated on the label and on the safety data sheet, which should, for example, also give information on what chemicals need to be separated from each other.