Today, EU countries' representatives in the so called REACH Committee agreed to the Commission's proposals to further reduce workers' exposure to 2 chemical substances of very high concern, following recommendations by ECHA. The decision will oblige companies that have applied to use chromium trioxide, a substance of very high concern due to its carcinogenic properties, to implement strict risk management procedures for various uses of the substance in the automotive, aerospace and other sectors. It also gives these companies a maximum of 7 years to reassess the availability of safer alternatives or substitute the substance earlier when possible. The REACH committee has also followed the Commission's proposal to, for the first time ever, reject the authorisation for continued use of sodium dichromate, an also potentially carcinogenic substance by a company using it for treatment of micro-surgical instruments. The Commission is due to adopt the above mentioned decisions in the coming weeks.
What are today's decisions about?
Chromium trioxide is listed in Annex XIV to REACH (Regulation (EC) No 1907/2006), as it is both carcinogenic and mutagenic. Consequently, it is considered to be a substance of very high concern and is subject to the authorisation requirement under REACH. Therefore, companies who use this substance must apply for authorisation.
The detailed conditions of each of the decisions are as follows:
- Authorisation will be granted to Lanxess Deutschland GmbH and others (also commonly referred to as the ‘Chromium Trioxide Authorisation Consortium’ or ‘CTAC’) for 6 different uses of chromium trioxide in a number of industry sectors. These include the aerospace and the automotive industries, covering more than 1500 sites and tens of thousands of jobs. As this application was marked by a number of weaknesses, the REACH Committee proposed to grant authorisation for a minimum time and under strict conditions. Companies within the consortium will have 3 months to revise their risk management measures and up to 18 months to confirm them on the basis of monitoring data. For some uses, they will have 2.5 years to improve their applications or submit new ones if they want to continue using the substance beyond the end of the review period, for others they will have around 3.5 years.
- A group of companies led by Gerhardi Kunststofftechnik GmbH will be authorised for to use chromium trioxide in chrome plating of plastic parts in the automotive industry for 7 years, instead of 12 as proposed by the European Chemicals Agency (ECHA) scientific committees. The aim of this reduced duration is to incentivise innovative development of substitutes for chrome–plating, by reviewing their availability earlier than recommended by ECHA.
- For the first time, the Commission also proposes to refuse an authorisation. It concerns an application by the company HAPOC GmbH & Co KG for the use of sodium dichromate in a particular (molten bath) form for the treatment of certain medical instruments for micro-surgery. The application did not conform to the information requirements in REACH, lacking sufficient elements to assess the risk associated with this use, and failing to provide such information on request. Therefore, along ECHA's recommendations, the REACH Committee voted not to grant authorisation.
What is the authorisation process and is it working?
The authorisation process for the most hazardous chemicals is a process introduced by the REACH Regulation in 2006. It aims to properly control the use of dangerous chemicals, and where possible, substitute them with safer ones. Users of such chemicals must send applications for authorisation to the European Chemicals Agency (ECHA). These are first assessed by the Agency, more precisely by ECHA’s Risk Assessment Committee (RAC) and by the Socio-Economic Analysis Committee (SEAC). Based on their analysis, the Commission decides whether or not to grant authorisation and under which conditions. This decision is also voted on in the REACH Committee, composed of EU countries’ representatives.
The authorisation system is operational but still affected by a number of practical challenges and concerns. In particular, it is costly and burdensome for companies to prepare applications for authorisation with an uncertain outcome. For ECHA, the Commission and the national authorities, making sound decisions regarding the applications has also turned out to be a complex process.
This has caused significant delays in the decision-making process. In the 2018 REACH Review, the Commission recognised the problem and continues to improve and streamline the system. The Commission is also making a significant effort to reduce the backlog of decisions, today’s votes being part of that.
At the same time, a 2017 Commission study shows that the authorisation system resulted in a reduction of risks to workers, consumers and the environment, as well as in substitution of the most hazardous chemicals in many instances. This is because companies applying for authorisation to use dangerous chemicals are forced to improve their internal risk management and make efforts to search for alternatives to get authorisation.
Are today's positive votes caving to the industry, by allowing them to use these dangerous chemicals?
The REACH Committee, composed of EU countries’ representatives, carefully weighed all elements. It concluded that the conditions to authorise the use of chromium trioxide are met, although, under stricter conditions and for a shorter period of time. This gives the companies and their downstream users the chance to improve applications for authorisations. The REACH Committee also voted in favour of refusing an authorisation for the first time.
The decisions are based on evaluations provided by 2 independent scientific committees: the Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC). The committees recommended additional conditions, beyond the terms and measures described by the applicants. These terms should help the companies to improve risk management, emission monitoring, and encourage them to look for safer alternatives. These terms also allow companies to continue activities and preserve European jobs that could easily be transferred to other world regions.
Are these decisions too strict for the industry not allowing them to adapt?
Today, there are still many technological barriers to overcome to ensure the necessary quality for the use of alternatives to chrome plating in the car industry. Nevertheless, the Commission wants to create strong incentives for innovation and substitution of chrome plating, where feasible. With a shorter review period, the concerned industry is forced to consider alternative technologies in specific applications earlier. In case those alternatives will not have the necessary quality in due time, the industry has the possibility to request prolongation of the authorisation for some or all uses through a review report.
Why has there been a delay in taking these decisions? What is the status of the outstanding applications?
The reason for the delays is mainly due to the complexity of many of the applications (covering many uses and companies) and the complexity of the decisions to be taken. These require detailed legal, technical/scientific and socio-economic analysis (for example on potential alternatives in particular uses of chemicals).
The authorisation process requires a very detailed assessment from ECHA, the Commission and the EU countries, on a case by case basis. This is to check whether the company takes all the necessary measures to minimize the risk to workers, consumers or the environment, and whether enough efforts were made to substitute the substance by less hazardous alternatives.
More specifically for the chromates, this requires an analysis of the trade-off between, on one hand, the safety of aeroplanes, cars, quality of products, such as the long life of bathroom taps, and on the other hand the reduction of risks to workers and risks to users of equipment. Moreover, as chromium (VI) is not present in the final consumer article, those articles can thus be freely imported. This increases the risk of driving the production of parts out of the EU, endangering tens of thousands of jobs.
In total, the Commission received 72 applications for chromates authorisation, 36 of these have been decided. The remaining 36 applications are still ongoing.
- Date de publication
- 15 février 2019
- Direction générale du marché intérieur, de l’industrie, de l’entrepreneuriat et des PME