EXPORTS TO USA
REQUIREMENTS FDA
CAPT has the collaboration of a team specialised in FDA requirements. For those companies that export or want to export their products to the United States, CAPT offers a wide range of services adapted to the needs of each company:
FDA REGISTRATION (BIOTERRORISM LAW)
Bioterrorism Act
The events of 11 September 2001 reaffirmed the need to improve US security, including the food supply. Congress responded by adopting a bill called the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (commonly referred to as the Bioterrorism Act), which President Bush signed into law on 12 June 2002. There are four main sections of this law that affect food and beverage companies, but for practical purposes only two sections significantly affect Central American exporters: a) the Registration of the company and b) the Prior Notice notification.
Registration. The Registration requirement (section 305) is required since 12 December 2003 for any business that produces/processes, packages or stores food or beverages consumed by humans or animals in the United States.
CAPT offers the following services:
- Company Registration with FDA and US Agent (Bioterrorism Act)
- FDA and US Agent Registration Renewal (Bioterrorism Act)
LOW ACID CANNED FOODS (LACF)/ ACIDIFIED FOODS (AF)
In order for companies that produce low-acid canned foods (LACF) and acidified foods (AF) non-perishables to distribute and sell their products in the US, the FDA requires each establishment to obtain a Canned Food Establishment (CFE) registration. The FDA also requires producers to apply for scheduled processes, also known as a Process Application for each product, product style, processing method, type and size of each container. Each Scheduled Process Request is assigned a "Submission Identifier" (SID). To import AF and LACF, you must have both an FCE and SID.
Registration. Each LACF/AF production establishment must register its facility. FDA will issue a Canned Food Establishment number for each location (FCE number). Processors must then submit a separately scheduled process (SID) for each product and product style, and for each container size of all LACF/AF. Registrations must be made according to the FDA forms in each case.
CAPT offers the following services:
- Registration of establishments
- Product registration
- Performance of the tests required by the FDA, depending on the type of product and thermal process.
CONSULTANCY - HACCP, PROCESSES, BPF
The FDA's Federal Regulations establish a series of requirements that industries must comply with depending on the type of product and processes to which they are subjected. Although it is true that all food industries maintain a system based on Hazard Analysis and Critical Control Points, the FDA has drawn up a series of reference guides on which all the systems of companies exporting to the USA must be based.
CAPT offers the following services:
- Advice for the elaboration of HACCP Manuals according to FDA requirements.
- Adaptation of processes to FDA requirements.
- Validation/verification of processes according to FDA requirements.
- Internal Audits (Third Party Audits)
- Preparation and/or accompaniment during FDA inspections.
TRAINING
The FDA establishes a series of mandatory training for certain positions with responsibilities or relevance to the processes.
Our training:
- Delivered by highly qualified personnel with more than 14 years of experience in the different fields in which we offer this service.
- Training designed and adapted to the characteristics and needs of the companies, as well as to the profile of the attendees.
- Based on a practical methodology that allows the attendees to apply it immediately.
CAPT offers the following courses:
- BPCS (Better Process Control School)
- PCQI (Preventive Controls Qualified Individual)
- Seafood HACCP
- USA Labelling
MANAGEMENT OF SUBSIDISED TRAINING
CAPT offers its clients a free course management service through FUNDAE- Fundación Estatal para la Formación en el Empleo (former Fundación Tripartita).