CTNC together with Demos Global Group, an officially accredited entity by the FDA under the Third-Party Accreditation Program for Food[1] Safety is offering to all interested parties the new FDA Food safety certification. This certification is the only truthful way to proof that your company complies with the new food safety regulation (Food Modernization Act FSMA) and the regulatory status[2].

Also, within this program, CTNC and Demos Global Group as an officially accredited entity under this program, offers  to perform the second and third party audits in order to verify that the products, processes or systems in the food supply chain meet accepted food safety standards as per the USA new regulations.

The Current US Food Safety System

The USA food safety system differs from the other systems of proof of conformity such as supplier declarations, laboratory test reports or inspection body reports, as well as it differs from all the food safety certifications such as the ones under the umbrella of GFSI (BRC, FSC 22000, SQF, IFS amongst others).

FDA certifications as these are called by the industry are based on the results of tests, inspections and audits and gives confidence to the consumer that your organization’s food processing system[3] are being thoroughly evaluated against accepted all USA federal regulations including but not limited to the food safety industry standards by a competent third body fully authorized and accredited by the FDA in the USA.

Sistema de seguridad alimentaria EE.UU.


Spanish companies with FDA Certificate

There are many reasons why more and more companies in Spain request FDA certifications. Some of the main reasons are these:

1- The desire to gain a strategic advantage in the marketplace

Certification can represent a sign of food quality and safety to consumers-

2- Certification signifies good governance and corporate responsibility

3 – It becoming a common requirement for doing business throughout the food supply chain

4 – Compliance with insurance regulations in the USA

Since most of the business in the food industry that are not certified under these certifications will not be able to get proper product liability insurances in the USA.

 5 – Compliance of the requirement of the clients in the USA

More and more clients in the USA are requesting foreign companies to have this certification for the importers to be able to comply with their own regulation in the USA which is called “FSVP Foreign Supplier Verification Program”

FSMA regulation in Spanish companies

For the food and dietary supplement industry in Spain, as well as in any other part of the world to access these certifications, the personnel in the manufacturing facilities MUST be professionally train under the FDA standardized curriculums that were developed under the FSMA regulation as well as in prior regulations but still currently valid for full implementation as a USA regulation.

This FDA standardized trainings differ based on:

 1 -The type of product to be exported to the USA

 2 – The type of processing of the food or dietary supplement product

3 – The type of entity: manufacturer, producer or importer.

For example, that are expected to adhere to different standards and regulations in the USA market. There are specific food safety standards and regulations for everything from the safe production and storage of fresh fruits and vegetables to packaging materials that have direct or incidental contact with food and beverage products and for example pre-requisites programs or good manufacturing practices for the dietary supplement industry.

Demos Global imparte cursos

FDA Training and Resources

These trainings are amongst other:

1 – The PCQI or Preventive Control Qualified Individual

Applicable to the entire food human industry in all its steps of the process.

2 – The PSR (Produce Safety Rule Training)

Applicable to the producer industry of fresh products destiny to be eaten raw.

3 – The HACCP for fish, seafood and fishery products

Applicable for these types of industries that manufacturers or participate in any step of the production chain for fish, seafood and fishery products.

4 – IA (Intentional Adulteration) Food defense Training

This IA training is mandatory for all personnel in a food facility that will have to deal with the creation, implementation, validation, and supervision of the Food Defense Plan.

The IA rule entered full effect and implementation on July 26, 2021, for the whole food industry (with few exceptions). As per this regulation the industry now MUST have to prepare a Food Defense Plan that meets completely the USA current regulation. This regulation also differs from the European standards as well as the voluntary standards implemented in the additional modules of the GFSI certifications such as (BRC, IFS and others).

Therefore, it is important for the personnel of the Spain manufacturing facilities as well as to all the other companies worldwide that have the intention to export food and dietary supplements to the USA to know the regulation and be professionally trained in these FDA standardized curriculums which are being continuously offered by CTNC together with Demos Global Group.

Demos Global Group

Regulatory audits

CTNC and Demos Global Group can help guide your business in the right direction by doing a “gap-analysis” to identify areas for improvement within a company’s operation(s) and to determine what type of path towards the certification would be most beneficial, whether it is a second, third party audit or the full certification process, besides the consultative or full regulatory audits that are conducted to prepare and certify your entity towards the USA market for you to proof that you fully complies with all  U.S. food safety requirements under the FD&C Act and FDA regulations as well as with industry standards and practices.

[1] In the United States of America, the concept of food, as supposed to the European Union, means all the food destiny to humans and animals, its ingredient, and sub-ingredients, dietary supplements for humans and animals as well as the food contact substances and food contact materials.

[2] Regulatory status under the current regulations means that your company MUST complies with all applicable regulations based on the type of food products you will be selling in the USA and the manufacturer process of these products.

[3] The certifications apply to the food processing systems and to the processes that an organization employs to make its products in a full compliance mode with federal USA regulations.