Jun. 13, 2018
The REACH regulation, related to the registration, evaluation, authorization and restriction of chemical products has been one of the great challenges for Europe´s chemical industry and has become a benchmark for other markets around the world. May 31 was the third and final deadline to comply with the registration obligations for substances manufactured in the EU or imported in a tonnage band between 1 – 10 t/year.
Following the commitment acquired since the regulation’s enforcement in 2007, Tradecorp has successfully submitted all the dossiers. After fulfilling the last deadline, which expired a few days ago, Tradecorp now fully complies with the REACH regulation. This guarantees the continuity of its products in the market, while simultaneously maintaining the respect for human health and the environment that is demanded from this regulation.
The Regulatory department has been working for over 10 years on the analysis, evaluation and registration of substances in order to meet this challenge. In some cases, this regulation has led to major changes in companies, which have had to adapt their procedures as well as their way of working. To gain a better understanding about these adaptations and the changes that the REACH regulation entails, today with us is Alexandra Castillo, Product Safety Manager: REACH & CLP in Tradecorp, since May 2016.
Question.- The REACH regulation imposes the responsibility on the industry to provide information on substances and to manage the risks of chemical products. The transfer of this responsibility entails large investments for companies that want to continue being part of the business and can be seen as a threat to smaller companies. Do you think that this regulation favors the stronger, more consolidated companies in comparison to other, smaller businesses as well as start-ups that may not have as many resources available to face such a demanding process?
Answer.- I think that, in spite of the ECHA’s efforts to facilitate the compliance of the SMEs with the obligations that the REACH Regulation implies, establishing, for example, lower registration fees, organizing instructive events such as webinars, publishing guidance documents, etc.., the impact is evident. SMEs have had to face processes that, for many of them, are complex and involve obtaining detailed and exhaustive information. Many SMEs have found themselves in the situation of losing suppliers who decided not to register substances they used as raw materials, forcing them to change their processes/products or having to face the economic cost of registering them. Some have had to make use of external consultancies to get the technical advice that they do not have within their own workforce and this, obviously, impacts not only SMEs, but in all types of companies in general.
However, the enforcement of the REACH Regulation also has a very positive side. REACH has forced the industry to get involved beyond mere compliance, getting companies to become aware of the importance of this regulation for the protection of human health and the environment. This awareness will undoubtedly have an impact on their industrial activities, now that companies are knowledgeable about their substances, how to use and manage them and, finally, how to protect their workers, thus improving the safety of the products. Consequently, we will have businesses that are much more specialized in their fields of action which, in the long run, will increase the competitiveness and the quality of the final products. Hazardous substances that until now had not been adequately evaluated, will be withdrawn from the market, taking them away from the workers and the final consumer.
Q.- The previous question could apply not only to smaller companies, but also to companies that focus on research and innovation. Do you think that REACH could lead to a halt on European innovation against other legislations that are more permissive?
A.- I am optimistic about the impact that the REACH Regulation will have on scientific research and development. In fact, one of its main objectives is to encourage R&D through the authorization process, since all substances that are classified as CMR (carcinogenic, mutagenic and toxic for reproduction) and / or endocrine disrupters will inevitably become part of Annex XIV of the REACH Regulation. This means that in order to use any of them, the specific company must provide ECHA with an action plan that includes the socio-economic justification for the use of the substance in question. This must be submitted together with a research and development program focused on finding alternatives that imply less risks for human health, which also are fully adjusted to sustainable development requirements. This will undoubtedly generate safer products, which will be better accepted in the target market and, in the long run, will have an impact on the positive image of the company.
Q.- One of the main objectives behind the REACH regulation is the knowledge of substances for the protection of human health and the environment. In what way would you consider that this regulation benefits the user / consumer and favors the protection of the environment?
A.- One of the main changes of the REACH Regulation was the transfer of the responsibility for the danger assessment of substances from the Member States to the industry. What used to be a centralized and slow process is now a more dynamic, fast and efficient process, since substances cannot be commercialized without compliance with REACH. This motivates companies to identify the risks of their substances and to establish management and control measures in order to comply with the regulation and stay in the market.
The direct consequence is that companies have been gradually feeding a huge database of substances that ECHA hosts on its website. New risks have been identified for many of these substances, as well as well as the perception of some that were previously not considered dangerous. All this information is now available not only to Member States and companies, but also to the general public.
The awareness campaigns led mainly by NGOs have aroused the interest of the consumer, who every day show a greater interest in the protection of health and the environment. Now the consumer has first-hand information about the chemicals they consume. This generates a movement of mass awareness that increases the pressure placed on industry; who is mainly responsible (not the only one) for a large part of the environmental and human health impact that chemicals cause on the environment.
Q.- The process of adapting to this regulation has been long and demanding. In the case of dynamic companies with a large R+D+I focus, and broad portfolios, such as Tradecorp; which launch many new products every year, this process has had to be even more complex due to the big amount of substances you handle. Tell us, how has the REACH implementation process been in Tradecorp?
A.- It has been a process that has not taken us by surprise, since we have been implementing it as required. However, we have had to allocate human and technical resources exclusively focused on achieving 100% compliance with the REACH Regulation, especially during the final stage of the registration obligation. The figures are a clear example of this final effort: since the entry into force of the regulation in 2007, we have registered a total of 30 substances, of which 15 were registered in the last deadline, which expired on May 31.
In addition, we are lead registrants for 7 substances. This makes TRADECORP one of the most committed Spanish companies to the REACH Regulation, especially considering the size of the company, the quantity of raw materials we handle and our portfolio of products.
In order to reach this stage, we had to face important changes within the company. They have been especially felt in our Regulatory Department, however we had the support of the other Departments to address the different challenges that were presented to us as we went through the process.
Q.- Today, Tradecorp is a company that fully complies with the REACH regulation. In general, what processes have been adapted so that Tradecorp continues to comply in a standardized way with this regulation and thus guarantee the continuity of its products in the market for the future?
A.- As I said before, we have been adapting as required by the REACH Regulation. If we take a look back at 2007, we see that many of our processes have changed: for example, the quality control of our raw materials. Right now, we have a strict control of evaluation of raw materials in relation to the information contained in the safety data sheets (SDS) that we receive from suppliers. The SDS must comply with the requirements of Annex II of REACH and must be accompanied by the corresponding exposure scenarios if necessary. Without this requirement, the raw material will not be accepted in our factories. Likewise, the substances that we receive must be duly registered at the ECHA.
Regarding our obligations, our products are properly evaluated, classified, labeled and packaged according to the requirements of the CLP Regulation. In the same way, they are always supplied with their SDS.
There is still a lot of work ahead. The REACH Regulation did not end on May 31 with the last deadline for substance registrations. On the contrary, now we face greater challenges: the development of new products in accordance with current regulations, the continuous improvement in the communication of hazards through safety data sheets, which are increasingly required to be more complete, and the development of new alternative products more environmentally and human health friendly. From here on, we still have a long way to go.
Alongside, REACH and CLP are not the only regulations currently in force. Tradecorp also carries out its industrial activity in accordance with local regulations throughout the world and even goes a step beyond. Due to our commitment to the protection of the environment and the sustainable use of natural resources, a large part of our effort in innovation is dedicated to the research and development of products that are not only effective, but also environmentally friendly.