KKDİK Regulation and Chemical Safety Assessment Expertise

In today's world, where communication has developed, expanded and accelerated like never before in human history, it now takes very little time for a development, news item or the effects of an application to spread globally. This allows us to follow new developments from around the world and stay informed about new trends. This naturally concerns industries closely as well. It is a fact that we are rapidly consuming the resources of the world we live in. In this sense, both the public and private sectors are now aware of the need to take steps and take action. Entrepreneurs have also come to realize the necessity of turning to more sustainable products in order to achieve long-term success in the market. In short, today a new invention or product has a chance of success only if it is sustainable and minimizes harm to the environment and people. Otherwise, no matter how useful and attractive the product is, it is impossible for it to achieve success in the long term and provide returns to its investors. Take the automotive industry, for example. No matter how cheap, practical or comfortable it may be, it is impossible to achieve long-term success by manufacturing a vehicle that consumes fossil fuel and has high CO2 emissions from this point forward. Certainly, the same example can be applied to all industries.

When viewed from this perspective, although shifting to less harmful and more sustainable products may seem to increase the cost of initial investment and entrepreneurship, when considered in terms of long-term perspective and sustainability, it will be seen to be closer to success.

When approached specifically in the chemical industry, it has always been in the spotlight, particularly with the industrial revolution in past periods. Yet it should not be forgotten that without the chemical industry, it would be impossible to ensure the welfare of humans and the environment under today's conditions. From plant protection products to disinfectants, from the pharmaceutical industry to food, chemicals and chemical products serve people everywhere and in every field. Therefore, what we need to do is use chemicals consciously both in industrial and daily life, and implement measures to eliminate their risks. For economic success, we also need to shift to sustainable products and products whose harm risks can be prevented and managed. Beginning in the 1980s and accelerating in the early 2000s, along with a trend driven by the United Nations as well as developed countries such as the EU, Japan and the USA, legislative developments have been taking place for the compilation of data on chemicals, the identification of their risks and their management. If we look at these developments under two headings, one of them has taken place in the field of hazard communication and the other in the field of compilation of scientific data on chemicals.

Hazard Communication

To briefly touch on it, under the leadership of the United Nations, the GHS (Globally Harmonized System) was designed for the communication of hazards related to chemicals and the measures that need to be taken by users to prevent these hazards. In our country, with the publication of the SEA Regulation on 11 December 2013, we took our place among countries applying GHS and brought our industry to the level of developed industrial countries in terms of global legislation and competition. As of 1 June 2015 for substances and 1 June 2016 for mixtures, the transition was made to SEA classification and labeling that is consistent with GHS. Of course, this transition brought financial burden and workload to the industry and caused difficulties during the transition process, but after this burden and cost were overcome, much like the pain that follows exercise in an athletic body, our industry improved hazard communication both in domestic and foreign markets and also increased its competitiveness.

Registration, Evaluation, Authorization and Restriction of Chemicals Regulation

Another development in the legislative field concerning the chemical industry is regulations that envisage using data obtained through the compilation of scientific data on chemicals to improve the use of chemicals. When approached from the essence of the matter, these regulations essentially invite chemicals to explain themselves. That is, rather than chemicals remaining under suspicion regarding their effects on the environment and human health, the aim is to compile scientific data about them, to determine through the evaluation of this data how their risks can be improved, and to make the use of those whose risks cannot be eliminated subject to authorization or restrictions. Now let us move on to the benefits these regulations will provide us: I find it useful to explain these using some current and vital examples. Cars are vehicles we cannot do without. Technological advances and high-quality roads being built enable us to travel faster and more comfortably with each passing day. However, on the other hand, as they speed up, they become more dangerous. To control this, the automotive industry develops new technological advances every day. Equipment that was not present in our cars in the past, such as airbags, tensioning active safety belts and many similar devices, keep us safe during journeys in our increasingly fast-moving vehicles and cause us to suffer less damage.

These types of equipment, which were a luxury option in the 70s and 80s, have now become a prerequisite for launching a vehicle on the market. The situation is the same with the regulations mentioned.

Since we cannot do without chemicals, we need to first compile data about them (Registration), identify their risks (Evaluation), and with various measures, improve and eliminate these harms if they exist. If this harm cannot be improved despite everything under certain conditions, we need to control its use under those conditions (Authorization) or ban it in some cases (Restriction). In developed economies, legislative work in this field dating back to the 1960s has been experienced and in each subsequent period, improvements have been made to further operationalize the system. Most recently, the REACH regulation published in the EU has emerged as the most comprehensive step taken in this regard and has created a global impact. Under the concept of "REACH like regulations," similar regulations have been put into effect in many countries. The USA, Canada, China, Malaysia, South Korea, Thailand, Taiwan, Japan and Russia can be listed as countries that have published regulations in this area and aim to bring chemicals under control. As the Turkish Republic, with the KKDİK (Registration, Evaluation, Authorization and Restriction of Chemicals) Regulation published in the Official Gazette on 23 June 2017 by the Ministry of Environment and Urbanization, legal requirements regarding this matter were put forward in our country as well. Yes, it is an undeniable fact that it will bring new burden and load to the industry, but when evaluated in terms of what it will bring and teach, it is also a fact that it will be developmental for our industry and increase its competitiveness.

Let us think a bit about the consequences of not implementing it and what it will bring when implemented. First of all, if you are going to impose restrictions on certain chemicals, as a rule of law and a member of the World Trade Organization, you must present reasons for this.

If you do not have data to subject to evaluation, on what basis will you prevent certain chemicals from being placed on the market in our country alone, in mixtures or within a product? This means we need a scientific basis and for this basis, we need data called the Registration file of KKDİK, so as not to become a dumping market where chemicals restricted in other countries can be sold. In this way, based on these data and after the evaluation by the competent authorities, we will be able to have data on the hazards of chemicals and their use, and through the evaluation of this data, we will be able to determine which chemicals we need to restrict or make subject to authorization. In a regulatory environment where chemicals are not subject to evaluation or restriction based on data, which consumer or intermediary can trust a product produced? Therefore, the implementation of regulations will ensure that products of our country's origin are preferred without loss of reputation and their sustainability in the long term. Similarly, when evaluated in terms of R&D, when evaluated in terms of the provisions that the KKDİK Regulation will bring, it will reveal the need for R&D activities to be directed towards sustainable products in terms of legislation. R&D activities that result in a chemical product or substance create the need to present a hazard assessment related to that substance from the outset. Otherwise, ultimately, as a result of hazards that cannot be controlled in the short term, you would have wasted significant amounts of money and labor on the discovery of a substance that could be quickly restricted.

Chemical Safety Evaluator under KKDİK Scope

One of the new concepts and obligations that the KKDİK Regulation has brought to industrial life is the requirement for a Chemical Safety Evaluator. One of the important differences of the Regulation compared to the EU REACH regulation is that Annex 18 contains chemical evaluation expertise and details regarding the training and examination of these experts. I believe that Turkish regulations in this field are being shaped with some past experiences in this area. Here is how; the first comprehensive regulation on the management of industrial chemicals was the "Control Regulation of Harmful Chemical Substances and Products" published in the Official Gazette No. 21634 dated 11 July 1993 by the Ministry of Environment at the time and came into effect, and is the first regulation determining the procedures and principles regarding the preparation and distribution of Safety Data Sheets. Following the implementation of this regulation, the "Procedure and Principles Regarding the Preparation of Safety Data Sheets" Circular was published in the Official Gazette No. 21634 dated 11 March 2002. Although the 5th Article of this circular states that "Safety Data Sheets, including update training, shall be prepared by appropriately trained professional persons," the failure to achieve a sufficient number of trained personnel in this sense led the authority to make this subject to an examination. Following this process, the 2008 Regulation on the Preparation and Distribution of Safety Data Sheets Relating to Hazardous Substances and Preparations (No. 27092) introduced the obligation for SDS preparers to hold examination and certificate qualifications. Although the regulation did not impose training as a condition, candidates had to attend training to succeed in the examination, and through this, a notable increase was achieved in the number of trained personnel in our country in this field and the level of knowledge obtained.

I believe all industry members, like myself, will appreciate the progress the sector has made in global competition terms through these training and examination programs.

Because before this examination and certification requirement, the number of people who could prepare labels and Safety Data Sheets that would be respected abroad, especially for export products, was at a level that could not meet the sector's demand. Although this provision seemed to bring a burden to the sector since it came into effect in 2008, today, both in the preparation of labels and SDSs for chemicals we export and in the preparation of labels and SDSs for raw materials we import in an understandable and regulation-compliant language, the role and contribution of this regulation and the examination provision it brought is significant. As the saying goes, pain that does not kill strengthens, and such obligations produce results that strengthen the competitiveness and global market image of our country's industry. A similar application is now coming before us with the KKDİK Regulation in the form of a "Chemical Safety Evaluator." Although the authority's objective to increase capacity and personnel in the industry in this sense will initially strain the industry, in subsequent periods it will enable the chemical safety evaluation of products we place on the market both in the domestic and global markets to be carried out by our companies' personnel and to be trusted and used by consumers or users.

Because as a country that has not been able to train personnel with the capacity to conduct chemical safety evaluations in this sense, we would have allowed this evaluation to be dictated to us by other countries and experts, and we would be faced with the possibility of having doors unjustly closed to our products.

According to the regulation's provisions and consisting of topics specified in Annex 18, Chemical Safety Evaluators must complete a total of 64 hours of training, and subsequently take examinations from institutions accredited by TÜRKAK according to the (TS EN) ISO/IEC 17024 standard, and upon scoring 70 or above, they will be eligible to obtain a Chemical Evaluation Expert Qualification Certificate. From this perspective, both through these training programs and through the examination and certificate to be obtained, our industry will achieve domestic and national labor force and competency capacity to comply with chemical control regulations that countries worldwide have put into effect through a chain effect, and will also increase awareness and consciousness among industry members in this field. With many of the regulation's provisions coming into effect on 23 December 2017, the Ministry will begin approving organizations and training programs that will provide training; subsequently, examination and certification organizations will first submit their programs to the Ministry for approval, and after this approval, they will apply for accreditation to TÜRKAK.