REACH-CLP and Biocidal Regulation Reports

The REACH Regulation requires that every type of chemical entering the European Economic Area (EEA) market—composed of European Union Member States, Norway, Iceland, and Liechtenstein—in quantities of 1 ton or more per year must be 'registered'. This means companies placing a chemical raw material on the EU market, either alone or within a mixture, must verify whether they have met the registration requirement. Registration must either be carried out by the exporting company itself, or the exporting company must obtain registered raw materials from its supplier. Following the REACH Regulation, registration of substances on the market as of 31 May 2018 was completed. However, the registration process continues for new substances entering the market. For a new substance to be registered, a 'Query/Inquiry' process must be followed. Under REACH, authorities will continue to take measures on harmful substances in the marketplace and introduce new regulations. From an industry perspective, beyond monitoring existing obligations, following the 2018 registrations, requirements such as the circulation of extended safety data sheets containing exposure scenarios in the supply chain, and correspondingly, risk management measures and operational conditions reflected in these forms will be implemented. Additionally, it is necessary to track updates on action-requiring lists such as the Candidate List, Restrictions List, and Authorisation List. Products entering the European market must comply with the REACH Regulation requirements.

What You Need to Know About REACH

Companies exporting to the European Union or working with customers in that situation must comply with REACH requirements regarding the raw materials in the mixtures they produce. REACH requirements must be verified for each raw material within a chemical mixture.

REACH Registration Obligation:

The REACH Regulation requires registration of raw materials produced in or entering the EU in quantities of 1 ton or more per year. Each raw material within a mixture must be registered separately. For exemptions, please consult our website. For a raw material subject to registration to legally enter the EU market, the registration process must be completed and a registration number obtained. Non-EU companies can register through a Single Representative. Your Single Representative will explain what is needed for registration and how to proceed.

Your registration costs consist of three components:

1. Single Representative fee, 2. Official registration fee, 3. Letter of Access fee (required to obtain access rights to information in the registration file). For registration fees, you can get an idea from the relevant link, but other fees vary in the market. Letter of Access costs vary greatly from substance to substance. (Some publish their prices online; you can research.) The process is generally time-consuming, varying with your company's decision-making and response speed.

Obtaining Registered Substances:

Another option besides registering is to enter the market by obtaining registered substances (benefiting from the re-import exemption). In this case, you must obtain registration numbers from your suppliers and communicate them to your customer. (Registration numbers must be provided for each substance in the mixture subject to registration.) Matters requiring attention that you should request your supplier to provide in writing: 1) Your use must be covered by the registration. 2) The tonnage you receive must also be within the registration scope (referred to as a tonnage certificate). Under these conditions, you can enter the market by obtaining registered raw materials without registering yourself.

Other Obligations:

Beyond registration obligations, you may have REACH obligations under the Authorisation-Subject Substances List in Annex XIV and the Candidate Substances List associated with it, as well as the Restrictions List in Annex XVII. The relevant lists and related information are available on our website. Additionally, the mixture must be classified according to the CLP Regulation, labelled, and a classification notification must be made. If the product contains hazardous substances or Candidate List substances above relevant thresholds, a Safety Data Sheet must also be prepared.

In summary;

• Substances on the Authorisation List cannot enter the European market unless authorization is obtained following an authorization application. (If an authorization-subject substance is present in the mixture at above 0.1%, authorization is still required) • If Candidate List substances comprise more than 0.1% of the product, customers must be informed. (Via Safety Data Sheet) • The Restrictions List requires certain raw materials to be used under conditions specified in the list. Otherwise, penalties, product recall, etc. may be applied. To fulfill registration and authorization obligations, companies in non-EU countries must appoint a Single Representative. The company designated as your Single Representative (REACH Only Representative) will guide you on registration and required information. REACH Global Services, established with İMMİB participation, can provide this service to you.

Responsibilities of Article Manufacturers Under REACH

The REACH Regulation primarily establishes rules on chemical raw materials. However, since these are also contained in manufactured articles, article manufacturers must also follow and comply with the relevant rules. Companies exporting articles to EU countries under REACH or providing supply services to such companies can access necessary information from the 'Articles and REACH' section of our website. Generally, article manufacturers' obligations can be found in the answers to the following questions.

What Does Article Mean Under REACH?

Under the Regulation, products whose shape, surface, or design is essential to their function are classified as articles. For example, yarn, paper, cups, furniture, and electronic goods are articles consisting of one or multiple parts.

I Manufacture Articles. What Do I Need to Do Regarding REACH?

There are two raw material lists to be followed regarding articles. If you use a chemical listed here in your product, there will be actions you must take. What must be done within these two lists differs.

Lists to Monitor:

Restrictions List: If any chemical listed in the first column of this list is used in your products and is manufactured in accordance with the conditions specified opposite it, the product can be sold as 'REACH-compliant' on the EU market. When products violating these rules are detected, authorities can recall them and apply penalties.

SVHC List (Candidate List):

If substances in your articles appear on the SVHC Candidate List announced by ECHA, and if the proportion of this raw material in the product is 0.1% by weight or higher, your customer must be informed with information such as 'the ... part of the product contains ... substance'. If you do not know all the raw materials you use in the product, you must query your suppliers. Obtain written responses (declaration letters) from them and keep them for any dispute situations.

Is Registration Required for Articles?

Articles themselves are not registered; however, in some cases, registration requirements for substances contained within them must be fulfilled. This exceptional case may be necessary, for example, with fragrant products where the manufacturer has designed a chemical emission. In this case, if each raw material in the mixture providing the fragrance enters the EU market at over 1 ton/year, a registration obligation exists.

Is There Any Notification/Registration/Declaration Obligation?

A notification obligation arises if substances in your articles appear on the SVHC list, reach the 0.1% threshold, and simultaneously this substance enters the EU at 1 ton or more per year. The notification process is free and can be performed by companies in Europe. If you communicate SVHC information and proportion to your European customer, they can handle the notification obligation. Registration requirements for articles are explained in the previous question.

State of Play in the CLP Regulation

The "CLP Regulation" is Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, which entered into force on 20 January 2009. Under the CLP Regulation, companies producing or importing chemical substances and mixtures in European Union member countries have the obligation to classify, label, and package these substances and mixtures according to the procedures and principles of this Regulation. This process in the EU began on 1 December 2010 for substances and 1 June 2015 for mixtures. In this context, product labels and Safety Data Sheets sent in exports to the EU must comply with the CLP Regulation and classification and labelling notification to ECHA must be completed. On the other hand, in our country, regarding the management of chemicals, within the scope of harmonization work with European Union environmental legislation carried out by the Ministry of Environment and Urbanization, the "Regulation on Classification, Labelling and Packaging of Substances and Mixtures" was published in the Official Gazette dated 11.12.2013, No. 28848, and entered into force. Under the scope of this Regulation, manufacturers and importers offering substances and mixtures to the market in Turkey were required to, from 1 June 2015 for substances and 1 June 2016 for mixtures, classify, label, and package according to the regulation's procedures and principles, and to provide classification and labelling information to the Ministry of Environment and Urbanization through the Ministry's notification system at http://online.cevre.gov.tr by 01.06.2015 to ensure effective protection against possible negative effects of harmful substances and mixtures covered under Article 40 of the Regulation on human health and the environment, and to establish a national classification and labelling inventory. Since the notification obligation will also replace pre-registration for substances after the publication of the national inventory, the classification legislation obligations are as important as the national inventory legislation in our country. However, as of June 2015, Safety Data Sheets (SDS) compliant with the Security Information Form (SIF) Regulation No. 29204 must be submitted for harmful classified chemical substances imported or produced. It is of great importance that companies in the chemical sector and all sectors supplied by this sector—those producing in our country, exporting to or planning to export to the EU, or providing supply services for export purposes—closely monitor and adapt to both pieces of legislation to avoid any problems.

Obligations Under the Biocidal Products Regulation

The Biocidal Products Regulation (EU) 528/2012, applicable in the European Union as of 01/09/2018, aims to ensure harmonization at Union level, protect human and environmental health at high levels, establish relevant conditions for the management of biocidal-treated articles, and establish detailed procedures and inspection mechanisms for biocidal products to be placed on the EU market. In this context, our companies exporting biocidal products to the EU must first identify the product type and make the correct selection of biocidal product authorization within the relevant product type scope.

Biocidal Product Authorizations vary in the number of countries they apply to and the product types that can be obtained, with details available on our website.

• National Authorisation. • Comparative Assessment of Biocidal Products. • Mutual Recognition. • Union Authorisation. • Simplified Authorisation. Another important matter under the Regulation is that under Article 95 of the Regulation, if there is no active substance supplier or supplier for biocidal products placed on the market in the EU, the manufacturer of the product using that active substance had to be listed in the Article 95 list for the relevant product type by 1 September 2015.

In this context, for our companies currently exporting biocidal products to the EU to prevent disruption of their exports;

• First, they must verify whether the active substance suppliers they use are listed in the Article 95 list published by the European Chemicals Agency for the relevant product type, • If active substances are obtained from a supplier outside the EU (since non-EU manufacturers are listed with their Legal Representative title in the EU in the Article 95 list), contact must be made with the supplier and confirmation letters recommended by the Commission confirming that the substance supplier/product supplier obligation has been fulfilled must be obtained. Furthermore, under the Biocidal Products Regulation, a substance, mixture, or article treated with one or more biocidal products or deliberately containing them falls under the definition of "Treated Article". Many product groups in various sectors fall into the biocidal-treated article group (ionizer-containing air conditioners, refrigerators treated with fungicide, textile products, etc.), and this situation is important. In this context, certain obligations began on 1 September 2016 for biocidal-treated articles to be placed on the market in the EU. Active substances used in treated articles must be accepted under the Regulation for the relevant product type and use. Active substances used in treated articles must be listed in Annex I of the Biocidal Products Regulation or must be accepted under the Regulation for the relevant product type and use. On the other hand, labels must be prepared according to relevant information and, within 45 days when this information is requested, must be provided to consumers free of charge. Labelling Requirement Furthermore, under the Regulation, a biocidal product manufacturer or importer must label their products in the following cases; • When there is a request relating to the article's biocidal products, • In matters required by the conditions associated with the active substance approval, considering the possibility of contact with people or release into the environment related to the active substance in question, Applications for approval of active substances contained in treated articles had to be made by 1 September 2016 at the latest. After 1 March 2017, it is not possible to place on the market an article treated with an unapproved active substance.

Situation in Turkey:

In our country, the Ministry of Health published the "Notification on Articles Treated with Biocidal Products" in the Official Gazette dated 13 May 2018 to establish procedures and principles regarding the supply to the market, presence in the market, packaging, labelling, market surveillance and inspection of articles treated with one or more biocidal products, and other matters related to treated articles. This Notification covers substances, mixtures, or articles treated with one or more biocidal products or deliberately containing one or more biocidal products, claimed to have biocidal properties or biocidal function. Treated articles can be placed on the market if the biocidal products with which they are treated or which they deliberately contain are licensed or registered in the biocidal product inventory for the relevant product type and meet the restrictions applied with respect to active substances. Under the Notification, manufacturers or importers must submit a technical file with a copy of the license and/or authorization of the biocidal product contained in the Treated Article they will place on the market, along with a label sample, and other requested documents. Furthermore, analysis by accredited laboratories with internationally accepted appropriate standards is mandatory to verify the biocidal function of treated articles and determine the period for which they will remain effective. Detailed information regarding legislation in our country can be accessed from the Turkish Public Health website.

Source: İMMİB REACH-CLP and Biocidal Assistance Desk