Agricultural Product Registration in Malaysia

Agricultural Product Registration in Malaysia | Bestar

Agricultural Product Registration in Malaysia

Registering agricultural products in Malaysia depends on the specific type of product. Here's a breakdown of the key areas:

Pesticide Registration

All pesticides manufactured, imported, or used in Malaysia must be registered with and approved by the Pesticides Board, which is under the Department of Agriculture (DOA). This is mandated by the Pesticides Act 1974.

Key Points:

• Definition of Pesticide: Includes any substance with an active ingredient or any preparation containing one or more active ingredients listed in the First Schedule of the Pesticides Act 1974 (which is updated periodically). This generally covers herbicides, insecticides, fungicides, and other pest control agents.

• Who Must Register: Any person or legal entity (must be a company registered in Malaysia with the Companies Commission of Malaysia - SSM) desiring to import or manufacture pesticides. The registration holder typically has the exclusive right to import the registered pesticide.

• Types of Pesticide Registration:

  • Proprietary Pesticides: Pesticides that are not classified as commodity pesticides.

  • Commodity Pesticides: Pesticides containing active ingredients that have been registered in Malaysia for at least 10 years. These generally have lower data requirements for registration. Mixtures containing both proprietary and commodity active ingredients are considered proprietary pesticides.

• Registration Data Requirements: Applicants must submit data online to the Pesticides Board, including test reports on:

  • Product chemistry

  • Toxicology

  • Environment

  • Efficacy

  • Samples

  • Labels Detailed requirements are in the "Guidelines on Registration of Pesticides" and "Guidelines on Registration of Biopesticides." Only one source (manufacturer) is allowed per registration.

• Application Procedure: Applications for new registration or re-registration are made using Form A and submitted online through the MyPesticide system.

• Fees:

  • Application Fee: RM 1,500 (non-refundable), payable upon submission.

  • Registration Fee: Varies based on the hazard class of the pesticide:

    • Class Ia & Ib: RM 3,500

    • Class II: RM 2,000

    • Class III: RM 1,000

    • Class IV: RM 500 This fee is payable before the Registration Certificate is issued.

• Registration Validity: 5 years, renewable 6 months before expiry.

• Timeline: Typically takes 2 to 3 years for new formulated pesticide products.

• Import Permit: Required for importing unregistered pesticides in limited quantities for educational or research purposes, or as registration samples. Applications are done online via the Dagang-Net e-Permit system. A certified copy of the valid registration certificate must be provided to the Royal Customs Department upon import.

• Re-registration: Applications for re-registration can be submitted not earlier than 1 year and not later than 6 months before the expiry date.

Fertilizer Registration

Malaysia is in the process of implementing a Fertilizer Act to regulate the fertilizer industry, which is currently under a system of "self-regulation." The Department of Agriculture (DoA) is taking steps to reinforce control mechanisms, including managing counterfeit fertilizers, and aligning with EU fertilizer regulations to promote exports.

Key Aspects (based on current understanding and ongoing developments):

• Organic Fertilizers:

  • Manufacturing requires a license from the Department of Agriculture Malaysia.

  • Compliance with the Malaysian Organic Scheme (myOrganic) standards is important as they influence organic fertilizer requirements.

  • Products must comply with Malaysian Standards (MS), particularly MS 1517: Specification for organic fertilizers, regarding composition and labeling.

  • Environmental regulations from the Department of Environment Malaysia regarding manufacturing processes (waste management, pollution control) must be followed.

  • General business registration with SSM is necessary.

  • An Information Form for Organic Fertilizers, Microorganisms and Other Items Related to Microorganism (MOBO Form) may be required for import applications, especially for organic fertilizers and products containing microorganisms. This form requires detailed information about the importer, exporter, product composition, manufacturing process, and effects on plants, livestock, humans, and the environment.

• Labeling: Fertilizer labels must contain important statutory information for transport, storage, and handling, including the chemical composition according to national regulations. Classification and labeling should adhere to national and EU regulations (CLP Regulation), and transport classification according to UN Transport of Dangerous Goods Model Regulations (TDG). The product origin must be stated on the bag.

• Importation: Importers may need to provide information such as the importer's and exporter's details, product name, quantity, and relevant certifications.

Other Agricultural Products

The registration or regulation of other agricultural products can vary. For instance:

• Food Products: These are primarily governed by the Food Act 1983 and the Food Regulations 1985, which cover food safety and quality standards, labeling, import/export, and advertising. The Food Safety and Quality Division of the Ministry of Health (MOH) is the main authority. Imports are subject to checks by the Malaysia Quarantine and Inspection Service (MAQIS). Certain products like meat, poultry, eggs, and dairy require halal certification from the Department of Islamic Development Malaysia (JAKIM).

• Plants and Seeds: The Protection of New Plant Varieties Act 2004 provides for the protection of breeders' rights for new plant varieties. The Department of Agriculture (DOA) is the National Registrar of Varieties.

• Animal Products: The Animals Act 1953 regulates the import and export of meat and poultry, generally requiring permits from the Director General of the Department of Malaysian Quarantine and Inspection Services. Halal certification is also crucial for products intended for Muslim consumers.

It is essential to contact the relevant authorities, primarily the Department of Agriculture (DOA) and the Ministry of Health (MOH), for the most accurate and up-to-date information regarding the registration and regulation of specific agricultural products in Malaysia. You may also need to consult with Standards Malaysia for applicable Malaysian Standards.

How Bestar can Help

Bestar can help in navigating the agricultural product registration process in Malaysia in numerous ways, offering expertise and streamlining what can often be a complex and time-consuming undertaking. Here's how:

1. Expertise and Knowledge:

• Understanding Regulations: Bestar possesses in-depth knowledge of the Pesticides Act 1974, evolving fertilizer regulations, the Food Act 1983, and other relevant legislation. We stay updated on the latest amendments, guidelines, and requirements from the Pesticides Board, the Department of Agriculture (DOA), the Ministry of Health (MOH), and other relevant agencies.

• Familiarity with Procedures: We are well-versed in the specific application procedures, documentation requirements, and online portals like MyPesticide and Dagang-Net e-Permit, ensuring accurate and timely submissions.

2. Efficiency and Time Savings:

• Streamlined Processes: Bestar can guide you through the registration process step-by-step, avoiding common pitfalls and delays. Our experience allows us to anticipate potential issues and proactively address them.

• Document Preparation: We can assist in compiling and organizing the extensive documentation required for registration, including test reports, safety data sheets, labeling information, and manufacturing details, ensuring compliance with regulatory standards.

• Liaison with Authorities: Bestar can act as a liaison between your company and the relevant government agencies, handling communication, addressing queries, and facilitating the review process. This can save you significant time and effort.

3. Risk Mitigation and Compliance:

• Ensuring Compliance: Bestar ensures that your products and registration dossiers meet all the legal and regulatory requirements, minimizing the risk of rejection, penalties, or market access issues.

• Data Interpretation: We can help interpret complex scientific data and present it effectively to the regulatory authorities, increasing the likelihood of a successful registration.

• Labeling and Packaging Compliance: Bestar can ensure that your product labels and packaging comply with Malaysian regulations regarding language, content, warnings, and hazard symbols.

4. Cost-Effectiveness in the Long Run:

• Avoiding Costly Errors: By ensuring accurate and complete submissions, Bestar can help you avoid costly delays, rejections, and the need for repeated testing or application processes.

• Efficient Resource Allocation: Our expertise can help you focus your resources effectively on the necessary tests and documentation, avoiding unnecessary expenses.

• Faster Market Access: A smooth and efficient registration process facilitated by Bestar can lead to faster market access for your products, providing a competitive advantage.

5. Specific Areas Where Bestar Can Assist:

• Pesticide Registration:

  • Selecting the appropriate registration category (proprietary or commodity).

  • Determining the specific data requirements based on the active ingredient and product type.

  • Preparing comprehensive registration dossiers, including product chemistry, toxicology, environmental fate, and efficacy data.

  • Navigating the online MyPesticide system for application and submission.

  • Assisting with import permit applications for unregistered samples.

  • Managing re-registration processes.

• Fertilizer Registration (in the evolving landscape):

  • Interpreting and complying with emerging fertilizer regulations and standards (e.g., Malaysian Standards, alignment with EU regulations).

  • Assisting with licensing requirements for organic fertilizer manufacturing.

  • Ensuring compliance with Malaysian Organic Scheme (myOrganic) standards.

  • Preparing necessary documentation for import applications (e.g., MOBO Form).

  • Ensuring accurate and compliant labeling.

• Other Agricultural Products (Food, Plants, Animals):

  • Navigating the Food Act 1983 and Food Regulations 1985 for food products.

  • Assisting with halal certification processes.

  • Understanding import/export regulations and liaising with MAQIS.

  • Providing guidance on plant variety protection and seed regulations.

  • Ensuring compliance with animal health and import/export requirements.

In conclusion, engaging Bestar can significantly streamline the agricultural product registration process in Malaysia. Our expertise, efficiency, and attention to detail can save you time, reduce risks, ensure compliance, and ultimately facilitate faster and more cost-effective market access for your agricultural products.

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