Page 148 - Veterinary Toxicology, Basic and Clinical Principles, 3rd Edition

Regulatory Aspects for the Drugs and Chemicals Used in Food-Producing Animals Chapter | 7 115

VetBooks.ir avicide, or molluscicide is authorized according to the (2) the authorization of biocidal products; (3) the mutual
recognition of authorizations within the union; (4) market
Directive 98/8/EC (EC, 1998a,b) it is also subject to clas-
sification, packaging, and labeling (CLP) according to
availability and the use of biocidal products within one or
Council Directive 78/631/EEC (EEC, 1978). The CLP more member states or the union; (5) the placing on the
introduces into the EU the globally harmonized system market of treated articles.
for classifying and labeling chemicals; this means that the The Regulation (EU) No. 528/2012 (EU, 2012) con-
same system is now used throughout the world. This will tains seven Annexes. Annex I: a list of active substances
enable workers and consumers to become more familiar referred to in article 25(a) (i.e., all the active substances
with the symbols and to get to know the effects of chemi- contained in the biocidal product appear in Annex I and
cals and how to use products safely. Companies need to satisfy any restriction specified in that Annex); Annex II:
notify European Chemicals Agency (ECHA) of the classi- information requirements for active substances; Annex
fication and labeling that they use for their chemicals. III: information requirements for biocidal products;
Article 5(1)(b)(iii) of Directive 98/8/EC (EC, 1998a) Annex IV: general rules for the adaptation of the data;
specifies that for biocidal products/active substances that, Annex V: biocidal product types and their descriptions as
as a result of their use, may lead to residues in food, referred to in article 2(1); Annex VI: common principles
member states shall ensure that products are only autho- for the evaluation of dossiers for biocidal products; and
rized if these residues have no adverse effects on human Annex VII, a correlation table.
health. An exhaustive list of 22 product types (PT) can be
Article 10 of Regulation (EC) No. 470/2009 (EC, found in Annex V of Regulation (EU) No. 528/2012.
2009a) provides for the setting of MRL for pharmacologi- Main group and product types that are relevant to sub-
cally active substances used in biocidal products used in stances that may be used in animal husbandry are shown
animal husbandry and specifies that the EMA is responsi- in Table 7.5 and therefore a MRL should be established.
ble for recommending MRLs for these substances.
Under the conditions of use, the biocidal products FEED ADDITIVES LEGISLATION
shall pose only a low risk to humans, animals and the
environment. An active substance cannot be included in The Regulation (EC) No. 1831/2003 (EC, 2003) sets out
Annex 1A (list of active substances with requirements rules for the authorization, use, monitoring, labeling, and
agreed at the community level for inclusion in biocidal packaging of feed additives. This regulation replaces
products) if it is classified as carcinogenic, mutagenic, Council Directive 70/524/EEC (EEC, 1970).
toxic for reproduction, sensitizing, or is bioaccumulative Directive 70/524/EEC (EEC, 1970) was fully reviewed
and does not readily degrade. Inclusion of an active sub- in 2003 and Regulation (EC) No. 1831/2003 (EC, 2003)
stance in Annexes I, IA, or IB (list of basic substances represented a major overhaul of the existing EU legisla-
with requirements agreed at community level) shall, tion on feed additives. All feed additives placed on the
where appropriate, be subject to the following require- market in the EU must be authorized under Regulation
ments on: (1) (a) the minimum degree of purity of the (EC) No. 1831/2003 (EC, 2003). The primary scientific
active substance; (b) the nature and maximum content of evaluation is conducted by the FEEDAP Panel of EFSA,
certain impurities; (c) product type in which it may be assisted by the European Union Reference Laboratory for
used; (d) manner and area of use; (e) designation of cate- Feed Additives. The scientific evaluation may include the
gories of users (e.g., industrial, professional, or nonprofes- setting of MRLs and follow-up regulatory control if
sional); and (f) other particular conditions from the required. Authorized additives in feed stuffs containing
evaluation of the information that has been made avail- provisional and permanent authorizations are listed in the
able in the context of this directive; and (2) the establish- Community Register of Feed Additives. A number of vet-
ment of the following: (a) acceptable operator exposure erinary medicinals listed under EC Directive 37/2010
level, if necessary; (b) where relevant, an ADI for humans (EU, 2010) may be incorporated in medicated feed with a
and a MRL; and (c) fate and behavior in the environment veterinary prescription. An example for a class of medica-
and impact on nontarget organisms. tion that falls into both categories (feed additives and vet-
The provisions of the last Regulation (EU) No. 528/ erinary medicinal products) is antimicrobials that are used
2012 (EU, 2012) on biocidal products are underpinned by for the prevention and therapy of coccidiosis in poultry,
the “precautionary principle,” the aim of which is to safe- rabbits, calves, lambs, and piglets. A limited number of
guard the health of humans, the health of animals, and the anticoccidial agents are approved for veterinary use.
environment. Particular attention shall be paid to the pro- These are listed in the Annex of allowed substances in
tection of vulnerable groups. This regulation lays down Commission Regulation No. 37/2010 (EU, 2010) such as
rules for: (1) establishment at the union level of a list of amprolium, decoquinate, diclazuril, halofuginone, lasalo-
active substances that may be used in biocidal products; cid, and toltrazuril. This annex contains information on