Improving the regulatory environmental risk assessment of human pharmaceuticals: Required changes in the new legislation.

One of the flagship actions of the Pharmaceutical Strategy for Europe is to address environmental challenges associated with pharmaceutical use. This includes strengthening the Environmental Risk Assessment (ERA) at marketing authorisation (MA) of pharmaceuticals, and revision of the pharmaceutical legislation where needed. The overall aim of an ERA should be to enable comprehensive and effective identification and management of environmental risks of pharmaceuticals without affecting the availability of pharmaceuticals to patients.

Safety and efficacy of an essential oil from (L.) Maton when used as a sensory additive in feed for all animal species.

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the seeds of (L.) Maton when used as a sensory additive for all animal species. Characterisation of the essential oil identified 37 components accounting for > 99% of its composition, with terpineol acetate (> 35%) and 1,8-cineole (> 20%) being the most prevalent compounds.

Guidance on the assessment of the safety of feed additives for the environment.

This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives used in animal nutrition. It specifically covers the assessment of the safety for the environment.

Safety and efficacy of Robenz 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening.

Following a request from European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Robenz 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz 66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a margin of safety of approximately 2.5.

Safety and efficacy of Deccox (decoquinate) for chickens for fattening.

Deccox, containing decoquinate as the active substance, is a feed additive intended to be used for the prevention of coccidiosis in chickens for fattening at a dose range of 20-40 mg/kg complete feed. Decoquinate from Deccox is safe for chickens for fattening at the highest applied concentration in complete feed of 40 mg/kg. No practically relevant interactions with other additives or veterinary drugs exist except with bentonite.

Safety and efficacy of Monteban G100 (narasin) for ducks for fattening.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Monteban G100 for ducks. Monteban G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60-70 mg/kg of complete feed. Narasin from Monteban G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed with a margin of safety of about 4.

Safety and efficacy of Monteban G100 (narasin) for chickens for fattening.

The feed additive Monteban G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60-70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as .

Safety and efficacy of Monimax (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying.

The coccidiostat Monimax (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat.

Scientific Opinion on the safety and efficacy of Aviax 5% (semduramicin sodium) for chickens for fattening.

The feed additive Aviax 5%, containing the active substance semduramicin sodium, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 20-25 mg/kg complete feed. Semduramicin sodium is present in Aviax 5% in its mycelial form and is produced by fermentation of spp. (ATCC 53664).

Assessment of the application for renewal of authorisation of Calsporin ( DSM 15544) for chickens for fattening.

Calsporin is the trade name for a feed additive based on DSM 15544. It is currently authorised for use in chickens for fattening, weaned piglets, chickens reared for laying, turkeys, minor avian species and other ornamental and game birds, and ornamental fish. This opinion concerns the renewal of the authorisation of Calsporin as a zootechnical additive for chickens for fattening.

Safety and efficacy of vitamin B (in the form of cyanocobalamin) produced by spp. as a feed additive for all animal species based on a dossier submitted by VITAC EEIG.

Cyanocobalamin is a synthetic form of vitamin B used in pharmaceuticals, supplements and as a food additive. It is intended to be used in feed for all animal species and categories. The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of cyanocobalamin produced by fermentation with strains SCM 2034 or CICC 11008s or strain CMCC (B) 70000.

Safety and efficacy of vitamin B (riboflavin) produced by ■■■■■ for all animal species based on a dossier submitted by BASF SE.

The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a riboflavin-based additive (minimum 80%) produced by a genetically modified strain of (■■■■■). It is intended to be used in feed for all animal species and categories. The additive under assessment does not give rise to safety concerns on the genetic modification of the production strain.

Safety and efficacy of betaine anhydrous for food-producing animal species based on a dossier submitted by AB Vista.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of betaine anhydrous produced ■■■■■ as a nutritional additive to be used in feed for all food-producing animal species except rabbits. Glycine betaine (betaine) acts as a methyl group donor in transmethylation reactions in organisms. Betaine occurs in numerous tissues of vertebrates as an osmolyte ensuring osmoprotection.

Assessment of the application for renewal of authorisation of Actisaf Sc47 ( CNCM I-4407) for lambs for fattening, minor dairy ruminants, horses and pigs for fattening.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the renewal of the authorisation of Actisaf Sc47 as a zootechnical additive for lambs for fattening, minor dairy ruminants, horses and pigs for fattening. In 2006, 2007 and 2008, the FEEDAP Panel adopted opinions on the safety and efficacy of Actisaf Sc47 when used in lambs for fattening, minor dairy ruminants, horses and pigs for fattening. Actisaf Sc47 is the trade name for a feed additive based on viable cells of CNCM I-4407 with no carrier.

Safety and efficacy of COXAM (amprolium hydrochloride) for chickens for fattening and chickens reared for laying.

The coccidiostat amprolium hydrochloride from COXAM is considered safe for chickens for fattening at 125 mg/kg complete feed. The margin of safety is at least 5. This conclusion is extended to chickens reared for laying.

Safety and efficacy of muramidase from DSM 32338 as a feed additive for chickens for fattening and minor poultry species.

The additive under assessment is a muramidase from DSM 32338 which is to be used as a zootehcnical additive in feed for chickens for fattening and minor poultry species. The production strain is a genetically modified microorganism. The introduced genetic sequences do not give rise to safety concerns and no viable cells and no DNA of the production strain were detected in the additive.

Modification of the terms of authorisation of lecithins as a feed additive for all animal species.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the modification of the terms of authorisation of lecithins as a feed additive for all animal species. Lecithins are currently authorised for use in feed for all animal species (Commission Implementing Regulation (EU) 2017/2325). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion of the additive lecithins in 2016.

Safety and efficacy of l-arginine produced by fermentation using KCCM 10741P for all animal species.

l-Arginine is considered to be a non-essential amino acid for most adult mammalian species, but it is classified as essential for birds, fish, possibly reptiles and also for strict carnivores. The product subject of this assessment is l-arginine produced by fermentation using a non-genetically modified strain of (KCCM 10741P). It is intended to be used in feed and water for drinking for all animal species and categories.

Safety and efficacy of l-arginine produced by fermentation with NITE BP-02186 for all animal species.

l-Arginine is considered as a non-essential amino acid for most adult mammalian species, but it is classified as essential for birds, fish, possibly reptiles and also for strict carnivores. l-Arginine produced by fermentation with NITE BP-02186, genetically modified to enhance the production of l-arginine, is intended to be used in feed and water for drinking for all animal species and categories. The product under assessment does not give rise to any safety concern with regard to the genetic modification of the production strain.

Safety and efficacy of Kelforce (l-glutamic acid, ,-diacetic acid, tetrasodium salt (GLDA-Na)) as a feed additive for chickens for fattening.

l-Glutamic acid, ,-diacetic acid, tetrasodium salt (GLDA-Na) (Kelforce) is sought to be used as a zootechnical feed additive in chickens for fattening to improve the absorption of zinc from feed, reducing zinc emissions through manure and thus, affecting favourably the environment. The product has not been authorised in the European Union as a feed additive. Kelforce is intended to be marketed as a liquid and solid formulation, containing ≥ 47% and ≥ 30% of GLDA-Na, respectively.

Safety and efficacy of Hemicell HT (endo-1,4-β-mannanase) as a feed additive for chickens for fattening, chickens reared for laying, turkey for fattening, turkeys reared for breeding, weaned piglets, pigs for fattening and minor poultry and porcine species.

Hemicell HT/HT-L is an additive that presents endo-1,4-β-mannanase produced by a genetically modified strain of . This additive is aimed to be used as a feed additive for chickens for fattening/reared for laying, turkeys for fattening/reared for breeding, weaned piglets, pigs for fattening and minor poultry and porcine species. In a previous assessment, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) established the safety of the additive regarding the production strain, target species, consumer and user.

Safety and efficacy of cumin tincture ( L.) when used as a sensory additive for all animal species.

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of cumin tincture ( L.) when used as a sensory feed additive for all animal species. The product is a water ethanol ■■■■■ solution, which contains 0.

Safety and efficacy of fumonisin esterase from DSM 32159 as a technological feed additive for pigs and poultry.

Fumonisin esterase produced from a genetically modified strain of is intended to degrade fumonisin mycotoxins contaminants in feeds for pigs and poultry. The production strain and its recombinant genes are not present in the final product. The applicant selected 300 U/kg feed to represent a likely upper limit.

Safety and efficacy of Taminizer D (dimethylglycine sodium salt) as a feed additive for chickens for fattening.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Taminizer D (dimethylglycine sodium salt) as a feed additive for chickens for fattening, based on a dossier submitted for the modification of the terms of authorisation of the additive. The product is authorised in the European Union for chickens for fattening at the maximum content of 1,000 mg/kg complete feedingstuffs. The applicant proposed the introduction of an additional manufacturing process, which introduces an impurity (dimethylamino-ethanol (DMAE)) in the additive at concentrations up to 0.

Safety and efficacy of Amylofeed (endo-1,3(4)-β-glucanase and endo-1,4-β-xylanase and α-amylase) as a feed additive for piglets and minor growing porcine species.

Amylofeed is a feed additive that contains glucanase, xylanase and amylase activities, and it is intended to be used as a zootechnical additive for weaned piglets and minor porcine species. In previous assessments, the additive was characterised and the safety for the target species, consumers and environment was established. Considering the safety for the user, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive should be considered as a potential skin and eye irritant and a potential skin and respiratory sensitiser.