Registration of Crop Health and Plant Nutrition Products in Japan

Plant health and nutrition products in Japan are regulated under the Agricultural Chemicals Regulation Act and approved if deemed safe in line with Good Agriculture Practice (GAP). Agrochemicals and biorationals are authorised strictly in accordance with their intended use, by specifying “application crop”, “application timing” and “application rate”. Farmers are only allowed to use plant protection products under the approved conditions of use.

Re-evaluation programme

Until recently, agrochemicals in Japan were subject to re-registration every three years. With time, the necessity for the regulatory plant protection reform in Japan became pressing,  as the market required more flexibility from the regulatory regime to integrate the latest scientific approaches and common agricultural practices. This was further accelerated by the widening gap between the regulatory requirements in Japan and new harmonised assessment guidelines increasingly applied internationally. Countering this, the Japanese government amended its Agricultural Chemicals Regulation Act on December 1st, 2018 by introducing a re-evaluation programme for active substances in the existing plant protection products.

The re-evaluation programme regulates the revision process by setting out clear timelines:

• Plant protection products registered after enforcement of the amendment act require re-evaluation approximately every 15 years
• Existing plant protection products are re-evaluated from 2021 according to a priority order.

Our Regulatory Services for Plant Health and Nutrition Products in Japan

Our experts offer full-scale scientific and regulatory services helping you register your crop protection products in Japan.  This also include support with all kinds of import tolerance applications and meeting the Japanese requirements for maximum residue levels (MRLs). For more details on Codex MRLs, visit our MRL website.

Our services at one glance:

• Evaluating the adaptability of the existing data package to the Japanese guidelines for plant protection products
• Examining the possibilities for read-across of available registration data authorised outside Japan
• Designing, contracting all necessary studies at contract laboratories in and outside Japan best suited to your needs
• Study monitoring and coordination
• Preparing and submitting registration dossiers to the Japanese competent authorities
• Compiling and submitting re-evaluation dossiers based on the Japanese “Shoroku” format
• Generating and filing registration / re-evaluation dossiers based on non-Japanese dossier formats (e.g. EU, U.S.)
• Liaising with and handling requests and comments by the Japanese authorities
• Handling all kinds of import tolerance applications and MRL setting.

Don't hesitate to contact our experts to learn how we can help you register your products in Japan.

KKDIK – Türkiye REACH

KKDIK (also known as Türkiye REACH) was enforced on 23 December 2017. The regulation applies to chemical substances (on their own, in mixtures or in articles) and requires that companies register all substances manufactured in or imported into Türkiye with volumes ≥1t/y.

After the pre-registration period had expired in December 2020,  the registration phase for all tonnage bands began in January 2021  and was initially planned to be completed by 31 December 2023. Due to considerable difficulties faced by the chemical industry in meeting the new requirements within the prescribed period, Türkiye’s Ministry of Urbanisation and Climate Change (MoEUCC) released an amendment to the existing regulation setting the following deadlines:

Companies based outside of Türkiye may appoint Türkiye-based Only Representatives (OR) to register substances on their behalf. The most striking difference to the EU REACH is that chemical safety reports (CSRs) must be generated by a locally certified expert under KKDIK.

Our Service

In cooperation with our renowned partner in Türkiye, CHEMLEG, we take care of your regulatory needs for the registration of chemicals and regulated chemical products. Our services include:

• Developing a regulatory strategy, including a testing strategy
• Planning and monitoring of studies
• Only Representative support through our local partner
• Registration services

Contact us to learn how we can help you make your chemicals compliant with KKDIK.

UK Pesticides Regulatory Regime 

After the Brexit on 1st of January 2021, an independent pesticides regulatory regime is in operation in Great Britain (England, Scotland and Wales).
In Great Britain (GB) the European law was retained in GB law, whereas the European legislations continue to apply in Northern Ireland (NI). The UK authority (HSE) remains the national regulator for the whole of the United Kingdom (Great Britain and Northern Ireland).

Active Substance

To maintain an active substance in the GB, it is necessary to send the application three years before the expiry date and submit the renewal dossier 33 months before the expiry date. Currently the requirements follow the retained regulation (EU) No 844/2012 and a copy of the EU dossier is sufficient under specific circumstances. Once new GB renewal requirements are agreed, an update of the supplementary dossier may be required prior to the beginning of the assessment of an active substance renewal.

The MRLs are still regulated in GB under retained Regulation (EC) No 396/2005. Many existing MRLs resulted from EU legislations adopted before the Brexit. These transferred EU MRLs remain valid until they are amended. For some active substances, the MRL granted in the European Union and Great Britain are already different.

Plant Protection Products

Plant protection products are currently evaluated according to the relevant articles of regulation (EC) 1107/2009. However, some new GB guidance documents are already available and have to be considered when applying for registrations. Further changes can be expected in near future. The dossier preparation and risk assessments are by now to be carried out according to available GB requirements by using specific GB templates.

For the preparation of studies, the application for trial permits should be considered. Trials permits are usually issued for three years.

For Northern Ireland the EU rules and laws continues to apply under the terms of the Withdrawal Agreement and Northern Ireland Protocol. Therefore, it is possible to mutually recognise an EU PPP authorisation in Northern Ireland. For this application a specific UK dRR is to be prepared. Also, applications for parallel trade permits are possible from the EU to NI.

SCC regulatory services in the UK (GB and NI)

For the UK market, we provide you the following regulatory services:

• Developing individual registration and compliance strategies for Great Britain and Northen Ireland
• Data gap analysis and (preliminary) risk assessments for all sections
• Planning and monitoring studies, including trial permits
• Preparing and submitting registrations, including follow-up and defence

 Please do not hesitate to contact our experts if you have questions or want to learn how we can help you ensure the regulatory compliance of your agrochemicals and biorationals, including adjuvants, fertilisers and biostimulants, on the UK market.

Our Services for Agrochemicals and Biorationals

SCC helps register your agrochemical and biorational active substances and products. Together with you, we develop sustainable registration strategies, prepare, submitt and defence your dossiers.

Contact our experts

They answer your questions and advise you on how you can make your agrochemicals and biorationals fit for your target markets.

Fill out the form below or contact us by This email address is being protected from spambots. You need JavaScript enabled to view it. or phone (+49 671 298460).

영국 REACH (UK REACH)

영국의 BREXIT로 인하여, 2021년 1월 1일부로 UK REACH 가 도입되었습니다. UK REACH 시행으로 인하여 EU REACH하에 등록한 물질들도 별도의 영국 REACH 대응이 필요하게 되었습니다. 화학 물질 또는 혼합물을 년간 1,000 KG 이상 영국에 판매할 경우, 등록 대상에 해당되며 등록 유예기간을 받기 위해서는 오는 10월 27일까지 DUIN (Downstream User Import Notification) 신고를 완료해야 합니다. DUIN 신고는 이미 영국에 등록 대상 화학물질을 판매하고 있는 경우에 한하며, 영국에 새롭게 판매할 계획이라면 등록을 완료한 이후에만 판매가 가능합니다.

UK REACH는 EU REACH의 목표와 원칙을 고수하고 있으며, EU REACH를 운영한 경험을 토대로 EU REACH와 매우 흡사하게 UK REACH를 운영할 것으로 예상됩니다.

SCC는 EU 화학물질 규제 30년의 경험으로 고객의 성공적인 영국 REACH 대응을 위하여 다음의 서비스를 제공하고 있습니다.

• 영국 유일 대리인 (Only Representative) 서비스
• Inquiry 작성 및 제출
• 등록 서류 작성 및 제출
• 자료 참조권 (Letter of Access, LoA) 구매 지원
• 규제 대응 솔루션 제공 (필요시, 등록 자료 생산 관리 포함)

EU REACH 경험이 있는 경우

EU REACH 경험으로 이미 EU REACH 등록 서류를 보유하고 계신 경우, 이용 가능한 자료를 최대한 활용하실 수 있도록 지원 가능합니다.

EU REACH에서 대표 등록한 경우가 아니라면, UK REACH 등록 용으로 자료 참조권 추가 구매가 필요합니다.

EU REACH 경험이 없는 경우

EU REACH 대응 경험이 없어 EU REACH 등록 서류를 미보유하고 계신 경우, 등록 절차상 필요한 대표 등록자와의 커뮤니케이션부터 등록 서류 작성까지 UK REACH 등록에 필요한 모든 절차에 대한 서비스를 한국어로 제공이 가능합니다.

UK REACH는 잉글랜드, 웨일즈, 스코틀랜드에만 적용되며, 북 아일랜드 (NI)는 기존의 EU REACH가 그대로 적용됩니다. 영국 거래처가 UK REACH 대응이 필요한지 EU REACH 대응이 필요한지 확인하시기 바랍니다.

Our Services for Chemicals

We provide you with full-scale support for your chemical regulation needs on the international level.

Contact our experts

They answer your questions and advise you on how you can make your chemicals fit for your target markets.

Fill out the form below or contact us by This email address is being protected from spambots. You need JavaScript enabled to view it. or phone (+49 671 298460).

Notification of Food Contact Materials in Japan

Starting from 1 June 2020, an amendment of the Japanese Food Sanitation Law is in force. It  provides that only substances evaluated for safety and listed on the positive list published by Japan’s Ministry of Health, Labour and Welfare are allowed to be used in food utensils, containers and packaging made of plastic. In addition to this, a Food Contact Material Safety Center was established within the Japan Chemical Innovation and Inspection Institute to supervise the enforcement of the new amendment and guarantee a smooth cooperation between the government and the private sector.

The amended regulation will be fully enforced starting from June 2025. During the transition period, food contact materials containing substances not on the Japanese positive list can continue to be placed on the Japanese market, if the composition of the material remains unchanged till May 31, 2025. Otherwise, only substances listed on the positive list can be used for the manufacturing of the plastic food contact material.

In addition to plastic food contact materials, Japan is planning future provisions for other materials in contact with food, such as paper, rubber, metal and glass.

FCM services in Japan

Our services include:

• Evaluating the conformity of your food contact material to the new requirements and positive list
• Defining and initiating hygiene test strategies
• Designing and monitoring of safety studies
• Preparation and submission of notifications
• Follow up after the completion of notifications

Our Services for Medical Devices

We help you carry out conformity assessments, prepare your medical devices for a market launch, and keep your documentation up-to-date.

Contact our experts

They answer your questions and advise you on how you can make your medical devices fit for your target markets.

Fill out the form below or contact us by This email address is being protected from spambots. You need JavaScript enabled to view it. or phone (+49 671 29846-177).

EURASIA REACH – TR No 041/2017

The regulation of chemical products within the Eurasian Economic Union (EAEU), consisting of Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia, is stipulated in the Technical Regulation (TR) No 041/2017, published in 2017. The TR, often referred to as Eurasia-REACH, requires legal entities to register their chemicals at the respective competent authorities in the EAEU member states before manufacturing or importing substances and mixtures into the EAEU countries. This requirement applies to all tonnages, but will be implemented in stages, depending on the tonnage. Producers and importers also need to provide Safety Data Sheets according to GOST Nr. 30333-2007.

Eurasia REACH itself has not been enforced yet, with its secondary legislation still in the draft phase. As it stands now, the legislation is expected to enter into force in November 2022. The first step in the implementation process, however, has already began, with Russia, as the first member state, having compiled a national chemical inventory via a notification process by the end of August 2020. Other EAEU member-states will follow suit and the intended date of completion of all national chemical inventories is set as 1 March 2021.

The Inventory Notification Process

As soon as the inventory notification process (“pre-notification”) has been successfully completed, the compiled joint inventory will list all existing chemicals on the Eurasian market. The notification process is not obligatory, however, all chemicals notified in the inventory, will be treated as “existing chemicals” in the EAEU after the TR No 041/2017 has entered in force. Chemicals not listed will be regarded as new substances in the EAEU and require a comprehensive study of their hazardous properties and a chemical safety report during notification (“registration”). This needs to be carried out before the chemicals are marketed in the EAEU.

Although the Russian inventory notification was closed in August, the full notification procedure has not been adopted yet. It is still possible to submit "pre-notifications" until June 2023 if the supplier/manufacturer is able to prove that the substance in question has been on the market before the entry into force of EAEU REACH.

Who can notify?

Manufacturers, importers and nominated representatives (NR) based in an EAEU country can notify substances and mixtures in the inventory. In case of NR, each importer in the EAEU would become a downstream user whose compliance obligations are covered by the representative.

What substances to be notified?

The inventory notification applies to all existing chemicals or those planned for use on the Russian market, with certain exception, such as:

• Pesticides
• Medicines, incl. veterinary medicines
• Food products
• Perfume and cosmetic products
• Chemical products intended for, or resulting from, research
• Minerals that have not been chemically altered.

The notification is possible for all substances on their own or in mixture at a concentration higher than 0.1 wt%. For polymers, this applies to monomers, stabilisers, additives and polymerisation initiators.

Our Eurasia REACH Services

Together with our partner, Pravsky Consulting, we can offer you the following chemicals regulatory services on the EAEU market:

• Notifying chemicals in the EAEU inventory
• Classification and labelling
• Nominated representative services through our local partner
• Communication with the competent authorities
• Services related to the future registration obligations under Eurasia REACH

For more information on Eurasia REACH, please don’t hesitate to contact our experts.

Our Services for Biocides

Together with you, we develop the appropriate dossier strategy for your target markets. We prepare, submit and defence your biocidal active substance and product dossiers.

Contact our experts

They answer your questions and advise you on how you can make your biocides fit for your target markets.

Fill out the form below or contact us by This email address is being protected from spambots. You need JavaScript enabled to view it. or phone (+49 671 298460).

Registration of Agrochemicals and Biorationals in the Eurasian Region

In the Eurasian Econimic Union, the regulation of pesticides and agrochemicals and Maximum Residue Limits (MRLs) is set forth in the provisions of the Unified Sanitary-Epidemiological and Hygiene Requirements for Commodities Subject to Sanitary-Epidemiological Surveillance (Control). The regulation was amended in 2015.

Together with our partner Pravsky Consulting, we provide comprehensive regulatory services helping our clients to bring their plant protection products to the  markets of the Eurasian Economic Union (Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan). 

Our Regulatory Services for the Eurasian Region

• Nominated representative services through our local partner
• Data gap analysis
• Developing individual registration strategies
• Planning and monitoring studies
• Preparing and submitting registrations and notifications, including subsequent follow-up and defence
• Communicating with the competent authorities
• Translating documents into the local language

Please contact us to learn more how we can guide you to the Eurasian regulatory markets.

Registration of Crop Health and Plant Protection Products in India

In India, we work closely with our partner This email address is being protected from spambots. You need JavaScript enabled to view it. to offer comprehensive regulatory services for the plant health and nutrition sector including the following fields:

• Agrochemicals
• Biorationals and biostimulants
• Plant / insect growth regulators
• Post-harvest fumigants
• Control of house-hold and nuisance pests
• Public health pest control

Our cooperation helps to ensure you gain double the benefits: On the one hand, from SCC’s in-depth scientific and project management expertise and, on the other, from our partner’s broad understanding and vast experience of the Indian market coupled with a well-established regulatory network.

Our Regulatory Services for the Crop Health and Plant Nutrition Indurstry in India

Do you have any questions or want to learn how we can support you in India? - Please contact us.

Registration of Disinfectant Products in the Eurasian Region

We work closely with Pravsky Consulting specialised in providing regulatory professional services for agricultural, public health and environmental sectors in Eurasia countries. Together with our partner, we offer full-scale regulatory support for the registration and notification of disinfectant products in the Eurasian Economic Union (Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan) as well as  Ukraine, Uzbekistan and Tajikistan.

Our Regulatory Services for the Eurasian Region

• Nominated representative services through our local partner
• Data gap analysis
• Developing individual registration strategies
• Planning and monitoring studies
• Preparing and submitting registrations and notifications, including subsequent follow-up and defence
• Communicating with the competent authorities
• Translating documents into the local language

Please contact us to learn more how we can help you make your disinfectants compliant with the regulatory requirements for the Eurasian markets.

Registration of Crop Health and Plant Nutrition Products in Latin America

We work closely with several members of the Latin American Network of Consultants (RED LATAM) specialised in Regulatory Professional Services for the agricultural, public health and environmental sectors in Brazil, Paraguay, Uruguay, Argentina, Chili, Peru, Ecuador, Colombia, Guatemala, Costa Rica and Mexico.

Through our partner network in Latin America, we offer comprehensive regulatory services for:

• Agrochemicals (chemical pesticides)
• Microbial pesticides for agricultural use
• Microbial pesticides for domestic use
• Biorationals and biostimulants

We work closely with our partners to ensure you gain double the benefits: On the one hand, from SCC’s in-depth scientific and project management expertise and, on the other, from our partner’s broad understanding and vast experience of the local markets in Latin America and their good relationship with the relevant authorities.

SCC services for Latin America

We offer you the following regulatory and scientific support:

• Data gap analysis
• Developing individual registration strategies
• Planning and monitoring studies
• Environmental fate and modelling / human and ecotoxicological risk assessments
• Addressing scientific and regulatory issues in physico-chemistry, identity, equivalence, residues and efficacy
• Preparing and submitting registrations and notifications, including subsequent follow-up and defence
• Communicating with the competent authorities and local partners
• Translating documents into Spanish and Portuguese

Please contact our experts to learn how we can guide you to the Latin American regulatory markets of your choice.

Türkiye Biocidal Product Regulation

Biocidal products need to comply with the requirements of the "Turkish Biocidal Products Regulation" dated 31 December 2009 and numbered 27449 published by the Ministry of Health. Biocidal products can be placed on the market in Türkiye after successfully receiving a license.

Companies based outside of Türkiye may appoint Türkiye-based Only Representatives (OR) to take over the tasks and responsibilities of Biocidal Product Applications under the Biocidal Product Regulation.

The process to receive a Biocidal Product License in Türkiye is a 3-step one:

1. Provisional Application Process: submitting documentation, such as label, safety data sheet, formulation and specifications and other required information on the biocidal product for evaluation and approval of the Provisional Application by the Ministry of Health;
2. Sampling and testing: performing analysis and testing on the biocidal products, as required by the Ministry of Health;
3. License process: submitting test documentation, such as chemical analysis, physical testing, short-term stability tests and efficacy tests for evaluation and final license approval by the Ministry of Health.

Our Service

In cooperation with our renowned partner in Türkiye, CHEMLEG, we take care of all your regulatory needs for your biocidal products. Our services include:

• Developing individual regulatory strategies, including testing strategies
• Study planning and monitoring
• Preparing and submitting approvals, incl. follow up and defence
• Communicating with responsible authority
• Only Representative support through our local partner
• Local support via our partner
• Translations into Turkish

Contact us to learn how we can help you bring your biocidal products to the Turkish market.