A food product’s label is how it communicates with the consumer. The written information includes the product’s composition, nutritional values, health claims, marketing messages, and more.

Every detail on the package can have a regulatory impact. Displaying erroneous or misleading information, even in good faith, exposes the manufacturer, importer, retailer or distributer to allegations from authorities and consumers and might have severe implications, including consumer harm, product recall, litigation and damage to brand reputation.

The Service Includes:

Label formulation – constructing and adapting the written information according to product specifications and providing a summary document with the required marking, according to legal requirements per country.
Label examination – examining and validating an existing label based on regulatory requirements. In addition, other elements are verified, such as illustrations, marketing information, and any additional relevant information. A report will be submitted that exhibits any detected discrepancies. This report will allow for amending the label and will reduce harmful exposure to the company due to incongruencies.
Creating nutritional labeling – generating a nutritional labeling table based on databases. The nutritional labeling table is calculated adhering to nutritional labeling regulations and complies with regulatory requirements, including health claims.
Kosher labeling – generating and validating Kosher marking, adhering to the requirements of the Chief Rabbinate of Israel and/or other relevant religious authorities. A report will be submitted that exhibits any detected erroneous information.
Petfood labeling – generating and validating petfood labels according to international regulation including FEDIAF and AAFCO. Labels can be reviewed for nutritional information by our veterinary nutrition and regulatory specialists. For more information, please get in touch with our office by email: sreut@2sher.co.il

Food regulatory affairs pose especially significant challenges to manufacturers, importers, retailers and distributers new food ingredients when dealing with innovative technologies, or using materials and equipment that have never been used before. Even in the initial development stages, awareness of the relevant regulatory requirements for the product, market, and target consumer is essential. The aim is to ensure that the development process is directed in a manner that adheres to the requirements, allocates the budget efficiently, and allows for proper scheduling.

Expertise regarding regulatory requirements is also essential in fundraising and collaborating with other companies in the field. Our company has a vast knowledge the “regulatory language” of various target markets around the World.

In addition, we maintain professional relationships with law firms and regulatory consultants specializing in food and with extensive regulatory experience with food startup companies.

The Service Includes:

• Reviewing the regulatory status of the product/technology
• Constructing a work plan to adhere to regulatory requirements in various target markets*
• Novel Food registration different countries
• Compliance/registration of products or technologies in the U.S. according to the relevant options: o GRAS (Generally Recognized As Safe) o FCM – Food Contact Materials o NDI – New Dietary Ingredients o Food additives o Dietary supplements
• Constructing/adapting packaging labeling to all target markets
• Outsourced regulatory management for companies and ongoing support for the needs of regulators, investors, customers, and suppliers * The United States (also at the state level), Canada, EU (also at the member level), Australia and New Zealand, South America, England, Russia, Ukraine, Japan, China, the United Arab Emirates, the Middle East, and North Africa (Palestine, Egypt, Jordan, Morocco and more). For more information, please email Reut Sharon at sreut@2sher.co.il

If a manufacturer or importer is sued in a class action lawsuit, they may require an expert opinion regarding regulations to assist the attorney on behalf of the defendant.

An expert opinion in food regulation requires professional expertise, in-depth familiarity with the local and international industries, creativity, and the ability to compile data to enhance the specialized review.

The opinion provided is derived from a comprehensive examination of the relevant subject as indicated in the claim and its various documents. It is based on regulatory surveys, literature, materials obtained from the client, and our professional experience.

The opinion is provided by our experts.

“The Protection of Public Health (Food) Law, 5776-2015” and the Israeli Ministry of Health’s procedure for importing food place the responsibility on importers. The product’s compliance with the requirements of the country of manufacture does not indicate compliance with Israel’s requirements.

Therefore, importers must ensure that the products adhere to local requirements. The National Food Service differentiates food imported to Israel by “sensitive food,” “sensitive food in the European path,” and “regular food.” The import process is different for food products defined by the Ministry of Health as sensitive compared to the import of regular food. Importing food and dietary supplements can be complex.

We employ an experienced team specializing in food regulation. The staff is well versed in legal requirements and proficient in examining import files and labeling.

The Service Includes:

The service is tailored to the needs of the organization and includes managing the import process:

• Importer and warehouse registration
• The import license renewal and/or updating data on the import license
• Complete management of the import license
• Monitoring the import license validity, including warehouses and relevant documents, until the updated license is obtained
• Constructing an import portfolio for regular, sensitive, sensitive foods in the European path and dietary supplements
• Creating labels and validating markings
• Constructing and validating safety files for dietary supplements
• Raising flags on issues that require the importer’s collaboration for risk management
• Overseeing the case with the Ministry of Health while working directly with the manufacturer until obtaining import permits
• Import permit renewal
• Changes to import permits, including re-validation of documents
• Complete management of the import file – validity monitoring, supervision certificates, and relevant documents in the file, including working with the manufacturers for renewal
• Working directly with customs to assist in the process of releasing goods when necessary
• We also offer parallel services for the importation of feed and petfood including labeling and representation at the Israeli Ministry of Agriculture and Veterinary Services. For more details, please get in touch with Reut Sharon by email: Sreut@2sher.co.il

Food regulatory surveys help manufacturers and importers compile regulatory data from various sources around the globe.

The surveys support the company’s decision-making process in various contexts:

• Product Development
• Product Safety Risk Survey 
• Food ingredient or product approval with the regulator
• Update product standards
• Provide additional information concerning legal claims We employ various regulatory specialists with extensive experience in composing dozens of specified regulatory surveys and adapting them to the client’s specific needs.
  
  

The Service Includes:

• Understanding consumer needs (Knowledge Gap): the purpose of the analysis
• Central regulatory sites review, such as the European Union, U.S. (FDA, USDA), Codex (WHO/WTO), Canada, New Zealand, Australia, and other destination countries
• Compiling and analyzing relevant articles
• Producing a customized document tailored to the customer’s needs
• For more information, please get in touch with our office by email: sreut@2sher.co.il