Registered B11 Laboratories program
Reliable laboratory analyses are crucial for a strong and trustworthy feed safety chain. Inaccurate or false analysis results will undermine the faith in the strength of our feed safety chain, as well as endanger feed safety itself. In fact, several incidents, related to inaccurate analysis results, have occurred over the years, which led to confusion and stress among companies within the feed chain. Therefore, after careful consideration, GMP+ International has decided to start the Registered Laboratories program.
What is the GMP+ Registered Laboratory program?
As from January 1st, 2020, laboratories that analyze critical contaminants for GMP+ FSA (Feed Safety Assurance) certified companies (B1, B1.2, B2 and B3), shall be GMP+ registered. This new program is exclusively meant for three critical contaminants, being:
- aflatoxin B1,
- dioxins/dioxin-like PCBs/ non-dioxin-like PCBs,
- heavy metals
Laboratories can choose for which of the contaminants they want to register for. GMP+ Registered Laboratories shall meet the following performance criteria for their contaminant(s) of choice:
- LOQ (limit of quantification),
- Bias, and
- Measurement uncertainty.
They also shall participate in Proficiency testing.
What do GMP+ FSA Certified Companies need to do?
For companies that are GMP+ FSA B1, B1.2, B2 or B3 certified, this change means that from January 1st , 2020, they can only use GMP+ Registered Laboratories for the analysis of the critical contaminants. From July 1st 2019 through January 1st 2020, the analysis of the specific parameters can be carried out by a laboratory that has applied for registration at a certification body, in addition to laboratories that have already been registered.
- For an overview of registered laboratories click here
- For an overview of applied laboratories click here
How to apply for the GMP+ Registered Laboratories program ?
As of June 1, 2018, laboratories can start to apply to become GMP+ Registered Laboratory. Once laboratories have implemented the performance criteria, they can apply for GMP+ registration through an accepted GMP+ Certification Body. Please find all Certification Bodies here.
Primarily, audits will be carried out by desk study. On-site audits will be carried out if doubts arise. GMP+ Registered Laboratories will have to pay GMP+ International an annual fee. This annual fee can be found in the GMP+ C4.
- GMP+ B11: standard containing the requirements for registration and verification of laboratories;
- GMP+ BA11: appendix containing the performance criteria for registered laboratories, based on European legislation and ISO standards.
- GMP+ D3.21: This is a support document with guidelines to help companies with the implementation of the new requirements
- January 1st 2020: GMP+ FSA certified companies must use GMP+ registered laboratories.
- July 1st 2019 through January 1st 2020: the analysis of the specific parameters can be carried out by a laboratory that has applied for registration at a certification body, in addition to laboratories that have already been registered.
GMP+ International will send regular updates to all parties involved about our GMP+ Registered Laboratories program.
Questions? Let us know!
We are convinced that this change to our GMP+ FSA module will have an enormous positive impact on both feed safety and the trust in our valued chain approach. All GMP+ FSA certified companies will benefit from it. We understand this change will impact your business. If you have any questions, we encourage you to get in touch with your Certification Body, send us an email, or call our Helpdesk: +31 (0)70 307 4144.