REACH After 2018

REACH Since 2018 and Turkey's REACH-Like Regulation: KKDİK

The REACH Regulation, which introduced a completely new approach to chemical legislation in the European Union and was perceived by industry as 'a burden', has completed its most intensive first decade. The REACH registration process, which began with pre-registration in 2008, entered a new phase with the expiry of the transition period granted to companies for submitting their registration dossiers in 2018. In this new phase, both the registration and other processes under REACH continue to be applied. The slogan 'No Data, No Market' used in REACH awareness campaigns in Europe is perhaps more relevant than ever. This is because substances can no longer be placed on the market in the EU using a pre-registration number. For this reason, companies in the European Union have become more rigorous and questioning in monitoring their REACH registration obligations due to the effect of ongoing inspections and the end of the luxury of placing substances on the market using a pre-registration number. For Turkish companies, 2018 was an important turning point both in terms of questioning their compliance with the REACH regulation in the EU market and in becoming acquainted with KKDİK, Turkish legislation adapting REACH, and beginning to understand their obligations in the domestic market.

EU Regulation 1907/2006 on REACH has been in force since 1 June 2007.

In this context, all chemicals and articles placed on the market in the 31 countries implementing REACH (the 28 EU Member States plus Norway, Iceland and Liechtenstein) must comply with the rules of this legislation unless they fall within certain exemptions. Although the United Kingdom's withdrawal from EU membership this year brings new uncertainties for many companies, the market rules have not changed for companies in Europe or outside the EU. The REACH Regulation brings various obligations such as registration, authorization and restrictions, as well as basic responsibilities such as communication requirements, for all manufacturers targeting this market. By the end of 2018, the number of companies that had met the REACH registration requirement exceeded 14,000. These companies submitted more than 91,000 registration dossiers relating to approximately 22,000 substances to the European Chemicals Agency. During the 10 years of REACH implementation, nearly 200 substances were added to the Candidate List triggering various obligations under the regulation, and 43 of these were included in the List of Substances Subject to Authorization (REACH Annex XIV). The REACH Restriction List has been amended or modified repeatedly and continues to be.

REACH Registration Process Continues

A transition schedule was set for manufacturers for the registration process, which is a requirement under REACH that demands both cost and effort. This transition period started with pre-registration in the second half of 2008 and ended with 31 May 2018, the registration dossier submission deadline for low-tonnage substances. This date is sometimes incorrectly perceived as 'the end of the REACH period'. However, like other lanes under REACH, the registration process continues with continuous updates. REACH registration must now be completed before placing a substance on the market. According to the regulation, before the final registration of a substance can be completed, it must first go through a process called an 'inquiry'. For this purpose, an inquiry dossier must be prepared and sent to the European Chemicals Agency (ECHA). Currently, companies can only proceed with the relevant registration based on approval from ECHA at the inquiry stage. As with the registration process, non-EU established companies cannot act independently in the inquiry process. According to Article 8 of the REACH Regulation, the requirements for substances manufactured in Europe or entering the market from outside the EU are parallel; however, companies established outside the EU can only fulfill REACH requirements such as registration, authorization and notification through EU companies providing REACH Only Representative services. If we evaluate the Inquiry + Registration process from a company perspective, we can state that more time needs to be spent on the preparatory phase requiring analytical testing, substance identification and determination of use areas, and the inquiry process should be considered as a kind of preparation for registration.

In addition to new registrations and inquiry processes, it is important to recall the sensitivity of ECHA and EU authorities regarding the keeping of previously submitted registration dossiers up to date.

For various reasons (authority requests, changes made by the Lead Registrant to the dossier, changes based on company initiative), registration dossiers may need to be updated, and ECHA conducts various awareness campaigns using social media animations to remind companies of this requirement. Authorities and ECHA continue to evaluate substances and dossiers. Certain hazardous substances may be subject to special examinations. At the end of this process, where manufacturers' views are taken into account, decisions can be made to apply special measures for certain substances or additional information can be requested from companies. The evaluation process, representing the 'E' in REACH, can thus directly reflect on other letters—registration, authorization, restrictions—and show its effects in these areas.

Status of Final Products

Under REACH, registration is only for substances. Final products—those in the mixture or article category—are not subject to registration. However, REACH requirements for the raw materials in these products may also be questioned. Companies supplying articles to the EU market can continue by preparing declarations about the substances they use in their product contents within the scope of REACH. However, mixture suppliers may be required to submit serious documents and evidence showing that the registration requirement has been fulfilled for each raw material in the products they send to the EU market. Mixture manufacturers sometimes struggle while attempting to prove that their suppliers are covered under the registration numbers. Our advice as RGS to mixture manufacturers is to always supply REACH-registered raw materials and thus avoid the cost and workload created by registration. However, the registration of raw materials by suppliers may not be sufficient for REACH compliance of the final product. In principle, merely the indication by the supplier that the relevant raw materials are registered and the provision of registration numbers is insufficient to prove the REACH compliance of the final product to authorities. Yet, manufacturing companies exporting to the EU market must query and document that their firms are covered by their suppliers' registration numbers. REACH is one of the most comprehensive and complex regulations in the EU. Therefore, for all examinations and evaluations to be made here, it is necessary to be familiar with the regulation and its applications and not to overlook even the smallest detail. REACH Global Services' Audit and Certification service, offered to resolve queries faced by companies, has enabled and continues to enable many companies to access the EU market smoothly since 2011. Under this service, final products are subject to detailed audits on a raw material and supplier basis. The supply chain is examined link by link. REACH compliance is verified and documented. Non-compliance issues are identified and solutions are proposed. Once everything is brought into compliance with the legislation, a REACH Compliance Certificate specific to the product or product group is prepared.

Turkey's REACH: KKDİK Regulation

The Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals "KKDİK", also known as Turkey's REACH in the chemical sector, was published by the Ministry of Environment and Urbanization on 23 June 2017. Thus, a new stage was reached in the work on adapting EU chemical legislation to Turkey, which has been ongoing for many years. According to KKDİK, all substances manufactured or imported annually in quantities of 1 ton or more, either as individual substances or in mixtures, must be registered by no later than 31 December 2023. The registration process will be carried out by submitting a registration dossier containing data specified in the legislation to the ministry for registrable substances placed on the Turkish market.

Time Constraints for Registration

The registration process will consist of two stages: the pre-MBDF (Substance Information Exchange Form) creation period lasting until 31 December 2020 and the "Registration" procedure to be completed by 31 December 2023. While REACH registration deadlines vary depending on the hazard category and tonnage band of substances, under KKDİK all substances have the same registration period. Although the two dates set by the Ministry of Environment and Urbanization have led many companies in Turkey into complacency with the perception that 'there is more time for registration', these periods are considered quite 'limited' by European companies experienced in REACH and registration processes and cause concern. The main reason for this is that Turkey will complete in 3 years what Europe took up to 10 years to complete in the registration transition phase. Due to the joint registration process, companies need to discuss, debate and resolve many issues such as substance identity, data sharing and cost-sharing criteria. These processes were planned to be conducted within structures called MBDF in Turkey and SIEF (Substance Information Exchange Forum) in Europe. However, experience in Europe has shown us that since discussions and debates in SIEFs did not proceed sufficiently quickly in the past, consortia formed by certain producers as pioneers played a key role in the registration process. If the processes conducted by consortia had not existed, the REACH registration in Europe might well have turned into a complete chaos. The institutional infrastructure in Europe and the efforts of civil society organizations also helped the REACH process proceed over a 10-year period without major disruptions.

Turkey has approximately 4 years left to overcome all these stages. In fact, European companies that do not want to leave things until the last minute and know how difficult the process can be are already in motion.

The Ministry of Environment and Urbanization's (ÇŞB) online data system, the Chemical Registration System, is currently open for the submission of (pre-)MBDFs. In fact, according to an announcement made by the ÇŞB on 27 September 2018, 805 companies have submitted pre-MBDF information for 10,442 substances to this system to date. Although the deadline for pre-registrations is 2020, companies currently supplying products to the Turkish market should participate in pre-MBDFs at the earliest to comply with the law and begin taking roles in consortia according to the roles they wish to take in the market. In addition to registration obligations, restrictions and authorization procedures are of close concern to companies supplying substances or products to the Turkish market.

The restrictions listed in Annex 17 of KKDİK restrict or prohibit the placing on the market of certain substances alone or their use in articles and mixtures. Restrictions enter into force on 5 different dates specified in the KKDİK Regulation, and for the vast majority of them this process has already begun.

Substances to be included in Annex 14 of the regulation will be subject to authorization. The Ministry of Environment and Urbanization is expected to publish this list on its website starting in 2024. If authorization is not obtained by the specified deadline for substances listed in Annex 14 by manufacturers, importers or downstream users, the substance cannot be placed on the market or used. For manufacturers and importers, close monitoring of this list and developments in its procedures is of critical importance. Unlike REACH, under KKDİK the Chemical Safety Report included in the registration dossier must be prepared and signed by a certified qualified person. More detailed information on qualified experts and criteria for preparing the Chemical Safety Report is contained in Annex 18 of the regulation. Similar obligations exist under the Turkish SDS regulation and SDSs must be prepared in Turkish by a certified local expert. As of the beginning of 2024, the Safety Information Sheet Preparer designation will be replaced by Chemical Evaluation Expert. The issue of fees is also among the topics that interest our companies. The ministry has not yet set application fees for areas such as registration and authorization, but has stated in various forums that they will not be very high. The actual cost to the manufacturer will be borne not by the application fees paid to the ministry but by the fees paid for the data in the dossier. There are unfortunately serious legal complications regarding the validity in Turkey of the access rights to data purchased for registrations in Europe (the 'Letter of Access' obtained from European consortia).

Only Representative Decision

The Only Representative (OR) role and definition specified under Article 9 in the KKDİK regulation is equivalent in nature to Article 8 of the EU REACH regulation. Companies established outside Turkey and supplying chemicals to the Turkish market are obliged to appoint a local Only Representative to fulfill their pre-registration obligations. Since many local consulting firms with virtually no REACH experience are attempting to provide services in this area, we advise companies to make careful decisions when appointing an Only Representative. The correct Only Representative will play an effective role in preventing the money and time losses that could result from misinterpretation of the regulation and misleading information, as well as incorrect recommendations that could be made in Substance Information Exchange Forms. In summary, for chemicals currently placed on the market, we need to move quickly past the pre-registration phase, determine a registration strategy, begin discussions on data sharing and other matters as soon as possible, and embark on the 'KKDİK adventure' to see the difficulties we will face in this already time-limited process. REACH Global Services (RGS), in the framework of compliance with the KKDİK regulation, will continue to support the sector and maintain strong cooperation with it by providing Only Representative services and consulting services, leveraging the rich experience it has gained since 2008 in EU REACH legislation and EU and Turkish chemical legislation. Mutlu Demirkan Senior Advisor REACH Global Services (RGS)