EU Increasingly Stringent with MRL Requirements

Posted By: Selerant RSA


Since the start of the New Year the EU has promulgated a series of regulatory amendments aimed at refining the limitations for food maximum residue levels of

Antibiotic residues in Foods: Of singular interest amongst these new regulatory amendments are the refinements made to antibiotic MRLs in foods. The use of antibiotics in livestock is a topic of considerable controversy. While their utility in fighting bacterial infections affecting livestock is undeniable, one of the secondary and extremely desirable side effects from a financial standpoint include promotion of growth in livestock.

The 20th century has seen the rise of the “Superbug” or pathogenic bacterial strains resistant to almost all our available antibiotics. Over prescription of antibiotics is often touted as the primary causative factor for the rapid onset of resistance in bacterial strains such as MRSA; however an equally important and underappreciated factor is the level of antibiotic residues in the food we consume. Overuse of antibiotics in agricultural settings for both labelled (fighting infection) and off label (growth promotion) uses invariably filters down to humans, the terminal consumers in the agricultural food supply chain.

Scientists are only just beginning to elucidate the complexities of bacterial gene transfer and its role in development of antibiotic resistance. Our common perception of bacteria as outside hostile invaders has conditioned us to overlook a hugely significant potential causative factor in the development of antibiotic resistance, specifically the interplay between pathogenic bacteria and our commensal gut flora. Pathogenic bacteria become resistant to antibiotics in a process of natural selection, primarily due to the selective pressures exerted by antibiotic use. In the same way the commensal bacteria residing in our GI tract become similarly resistant. Evidence has shown that the genes that confer this resistance can be transfer even between bacteria of different species.

Since food constitutes the most significant external influence on our internal bacterial ecosystem, overuse of antibiotics in the food we eat causes proliferation of antibiotic resistance in our gut flora. This protective evolutionary process saves our gut flora from being completely wiped out during antibiotic use but is a double edge sword in that there is increasing evidence that genetic transfer between our gut flora and pathogenic bacteria is an underappreciated cause of our growing antibiotic resistance crisis. To combat this and many of the well documented health sequelae associated with over exposure to antibiotics the EU has made 3 Major Amendment’s to the MRL Standard for antibiotics which were promulgated on Jan 30th 2015.



(EU) 2015/151 of 30 January 2015 amending the Annex to Regulation (EU) No 37/2010

Doxycycline is a broad spectrum antibiotic used in a variety of applications. Most recently its claim to fame is due its usage as one of the last CDC sanctioned frontline treatments in the global battle against multiple antibiotic resistant Gonorrhea. The bacteria has over the last 20 years developed resistance to the majority of antibiotics available including successive generations of Cephalosporins and now even demonstrates prohibitively high level of resistance to Fluoroquinolones. Standard treatment now requires intramuscular injection of Ceftriaxone followed by a 7 day course of Doxycycline.


Gamithromycin and Tulathromycin

The labeled use of these macrolide antibiotics is to treat respiratory infections in cattle and pigs. Changes to their associated MRL levels in foods are articulated in the following regulatory amendments.

  • Gamithromycin: (EU) 2015/150 of 30 January 2015 amending the Annex to Regulation (EU) No 37/2010
  • Tulathromycin: (EU) 2015/152 of 30 January 2015 amending the Annex to Regulation (EU) No 37/2010


Adjustment of Corticosteroid MRLS in Foods

As of January 30th 2015 the EU has stipulated a new requirement for the limits of Methylprednisolone in food as articulated by (EU) 2015/149 of 30 January 2015 amending the Annex to Regulation (EU) No 37/2010.


Adjustment of Maximum Residue Levels of Food Contact Materials

As of February 5th 2015 the EU has stipulated new requirements for the limits of certain food contact materials as articulated by Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food, Commission Regulation (EU) 2015/174.


Adjustment of Maximum Residue Levels of Pesticides in Foods


  • As of February 3rd 2015 the EU has stipulated new requirements for the limits of certain pesticides in foods with specific reference to MRLs lactic acid, Lecanicillium muscarium strain Ve6, chitosan hydrochloride and Equisetum arvense L as articulated by amendment (EU) 2015/165 which replacing the stipulations as laid down in (EC) 396/2005.