We have in-depth knowledge of the laws that regulate biotechnology and novel foods, including authorisations and notifications under the simplified procedure. We regularly advise on the classification of borderline products (food vs. medicinal product), product authorisations, food packaging, labelling, nutritional claims, product recalls, and food safety. Before food products can be sold to the consumer, a thorough labeling compliance check is required. Our clients seek our assistance when designing product labeling and marketing. Failure to adhere to nutritional labelling, reporting, and notification requirements can lead to the product being taken off the market.
Food law aims at ensuring a high level of health protection. An integrated “farm to fork” approach is a general principle for European food safety policy. Food law, both at national and EU level, establishes the rights of consumers to safe food and to accurate information. Stakeholders include non-governmental organisations, professional associations, international trade organisations, food manufacturers, wholesale distributors, exporters, and importers.
European Union food law aims to harmonise national requirements in order to ensure the free movement of food and feed in the EU. Food law recognises the EU’s commitment to upholding international standards and a high level of consumer protection
European Regulation 178/2002 establishes three inter-related components of risk analysis (risk assessment, risk management, and risk communication). Risk analysis principles in relation to food safety underpin the scientific and technical evaluations undertaken by the European Food Safety Authority (EFSA).
In July 2019, EFSA’s Advisory Forum endorsed a Declaration of Intent on the principles governing the impartiality of risk assessment in the areas of food, feed, plant health, and animal health and welfare, and proposed to establish a Task Force on independence aimed at facilitating the exchange of information and best practices. Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain (the Transparency Regulation) entered into force on 26 June 2019, and will become applicable as of 27 March 2021.
In Malta, the Health Inspectorate that forms part of the Environmental Health Directorate within the Health Regulation Department of the Ministry for Health is tasked with ensuring that food produced, distributed, marketed, and consumed meets the highest possible standards of food safety and hygiene. This is achieved under the direction of the Food Safety Commission in collaboration with the other key players in the official control of food and feed in Malta under the Food Safety Act (Chapter 449 of the Laws of Malta). The Health Inspectorate is also responsible for implementing the environmental health policies under the Public Health Act (Chapter 465 of the Laws of Malta).
Services
We provide legal advice on:
Implementation of Regulation (EU) 1169/2011 on the provision of food information to consumers:
- labelling requirements and food label compliance with EU legislation
- trade names, origin designation, and geographical indications
- nutrient profiles and nutrition information on processed foods
- mandatory origin labelling of unprocessed meat
- allergen information and labelling legibility
- verification of packaging compliance with food regulations
Health and nutritional claims in compliance with European Regulation 1924/2006
Classification, labelling, notification, marketing and distribution of food supplements under the European Food Supplements Directive 2002/46/EC including:
- vitamin and mineral supplements,
- nutritional supplements
- herbal supplements
Classification, registration, distribution, and sales of food products including:
- nutritional beverages
- nutritional supplements
- meal replacement products
The European Novel Food Regulation (EU) 2015/2283:
- authorisation applications
- notification to government authorities
- labelling requirements
Regulation (EU) No 609/2013 of the European Parliament and the Council on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control (Food for Specific Groups), also referred to as PARNUTS.
- nutritional claims
- manufacture
- marketing and advertising
- mandatory labelling such as gluten-containing ingredients, with a scientifically proven allergenic or intolerance effects
- health claims
Chemical and biological safety and the use of food improvement agents
Product liability and consumer law throughout the food development process:
- product development / R&D
- marketing, promotion, and advertising
- distribution, import, and export
Malta food law, including:
- Food Safety Act (Chapter 449 of the Laws of Malta)
- Hygiene of Food Regulations
- Food Supplements Regulations
- Flavourings For Use In Foodstuffs and Source Materials For Their Production Regulations
- Permitted Food Additives Regulations
- Infant formulae and Follow-Up Formulae Regulations
We can also assist you on a full range of matters throughout the product and brand lifecycle:
- Legal research
- Incorporation
- Corporate Governance
- KYC and due diligence checks, and advice on Sanctions
- Mergers & Acquisitions
- Legal guidance on Import and Export
- Trader Registrations with the Food Safety Commission
- Port Health Services Notifications
- Customs legislation and declarations
- Supply chain, logistics, and distribution
- Negotiation, drafting and review of Commercial Contracts, including:
- Supplier Agreements
- Distributor Agreements
- Confidentiality Agreements
- Property contracts and leasing agreements
- Label Review
- Recall Management System
- Research and development
- Production and processing regulatory compliance
- Packaging and labelling regulatory compliance
- Advertising and marketing
- International expansion
- Brand diversification
- Intellectual Property including Trademark registration
- General Data Protection Regulation 2016/679(GDPR) compliance
- The use and impact of biotechnology
- Labelling and nutritional claim regulatory compliance
- Food law and health law compliance
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