Feed Safety for Speciality Feed Ingredients

Feed safety schemes are becoming an important feature of the global feed chain. Nowadays, feed business operators’ operational activities take place in a rather complex legal and business environment. Third Party Certification (TPC) against a feed safety scheme has become an important feature for the feed sector. Although TPC is voluntary, it is an important requirement for a feed business operator to gain market access.

As far as the Specialty Feed Ingredients sector is concerned, Third Party Certification (TPC) is becoming an important tool in supporting market access, at a global level.  Today, the feed sector is being confronted with a number of challenges, such, traceability in a larger scale, sourcing of raw materials at the global level, a variation on the regulatory environment from country to country, different feed safety cultural backgrounds.

FAMI-QS, the Quality and Safety System for Specialty Feed Ingredient started as a European project in 2004.  In 2003 Feed Hygiene Regulation was introduced in Europe. This regulation, EC 183/2003, laid down requirements for feed hygiene. The breakthrough of this regulation was that HACCP became a mandatory regulatory requirement for the feed sector. Following the implementation of the Feed Hygiene Regulation, a number of sector-specific schemes (derived from different feed industry sectors) have developed with the view to support the feed industry to implement the Feed Hygiene Regulation. Gradually, other regions like Australia, Canada, and the U.S.A. started to develop further their regulatory requirements for the feed sector as well. This month, the FDA published the final rule for the Preventive Controls for Animal Food.

In a very short period of time, FAMI-QS became not only the reference standard for harmonizing the EU requirements, turning into the tool to meet the legal requirements for the placing of specialty feed ingredients on the EU market but also it has become the reference standard for facilitating world trade of specialty feed ingredients. This is the third development phase, during which FAMI-QS certification’s trade flows have gone beyond the EU. Feed business operators are now certified against FAMI-QS to place their products in third countries, rather than only on the EU market.

Since 2015 the name of FAMI-QS changed from the European Feed Additives and Premixtures Quality System to FAMI-QS the Quality and Safety System for Specialty Feed Ingredients. The name change also reflects the adaptation of the FAMI-QS Scope. The driving force for the rewriting of the FAMI-QS scope was the fact that the same ingredient coming from a certain process, e.g. bioprocess, has a different regulatory interpretation depending on the country of production and destination. This means that the ingredient has a different status depending on the regulatory background of the country. For example, the same ingredient can be a feed additive or a feed ingredient, depending on the “regulatory” classification of the product, leading to different hazard risk management.

In FAMI-QS, the focus is on the common denominator: the production process. The term “Specialty Feed Ingredient” captures precisely the core sector and industry knowledge. The adaptation of the scope definition for international implementation will not change the range of ingredients eligible to be FAMI-QS certified. A specialty feed ingredient is defined as an intentionally added ingredient not normally consumed as feed by itself, whether or not it has nutritional value, which affects the characteristics of feed or animals/ animal products and animal performance.

The classification of the single ingredients and/or mixtures will be performed by the process they result from: independently where a specialty feed ingredient will be placed and its status (classified as a feed additive or feed ingredient), the common element is the process from which it comes from, e.g. bioprocess.

With the introduction of FAMI-QS Version 6 a number of changes were introduced:

FAMI-QS Code level of detail was improved. This allows for feed business operators to gain more guidance for the implementation of specific requirements and avoid misinterpretation, which at the same time enables the certified company to reflect on its own feed safety management culture against the implementation of FAMI-QS Feed Safety Management System. Fair play in the area is the key issue.

In addition, the new structure of the Code is aligned with the ISO- High-Level Structure. This will support the integration of all certification Management Systems in one quality manual (it doesn’t make sense for the operators to maintain multiple quality manuals). Furthermore, the new structure refines and enables the operator to undertake an integrated approach and not to address requirements in an isolated manner. Thus, all the chapters and requirements are now very closely linked with each other’s, allowing a holistic approach towards feed safety. In this context, the requirements of the code have been re-organized.

One of the core chapters of FAMI-QS Code, the Good Manufacturing Practices, was redesigned and the requirements were aligned with the requisites of ISO/TS 2003- Part 6 and FSMA CGMP Animal Food.

One of the most noticeable changes is the support for HACCP implementation, with the introduction of the process documents, in addition to the Code itself. These documents will provide an auditable HACCP plan, specific per each process covered under FAMI-QS and with specific hazards that need to be managed.

The feed business operator is the one placing the product on the market and has the responsibility for that. FAMI-QS provides a realistic, concrete and robust system to ensure the placing of safe ingredients on the market.

Besides its market value, a credible Third-Party Certification could also be a useful tool in the hands of the competent authorities regarding, e.g. planning of the official controls or “granting” market access to products or operators. Third Party Certification is not meant to substitute the responsibilities of competent authority but is increasingly recognized by a number of them as an important element, which not only supports their enforcement role but can also help setting state-of-the-art practices at the global level and as such facilitate understanding and exchanges at international level.

Governments and the citizens they protect are increasingly moving towards zero risk tolerance. Regulators are introducing stricter, and more comprehensive regulations and reporting requirements. Businesses are therefore required to demonstrate legal and regulatory compliance. The private standards and FAMI-QS, in particular, could act in a more efficient way in this regard and help regulators to shift in the direction of holistic public protection.

With the introduction of FAMI-QS Version 6, and in order to further support FAMI-QS certified organisations to meet the regulatory requirements, two new documents were introduced: a guide to managing regulatory compliance, which supports the operators to manage their compliance status and improve their capability to deliver regulatory compliance and the Markets Regulatory System, which provides a comprehensive compilation of the latest regulatory developments in several regions at global level: e.g. Europe, USA, Brazil.

Third Party Certification against a feed safety management scheme identifies the risks within a feed business organization with the ultimate goal to ensure feed safety by minimizing unsafe practices and the risk of hazardous ingredients entering the food chain. A ThirdParty Certification cannot eliminate a risk, thus feed business operators must have a very good understanding of their operational environment, deep knowledge of their products’ profile(s) and of their suppliers and ensure regulatory compliance.

All in all, organizations in the sector of Specialty Feed Ingredients can get the support they need to manage the feed safety risks through FAMI-QS.
by Emmanuel (Manolis) Geneiatakis, FAMI-QS Asbl