CHAPTER IV

GENERAL AND FINAL PROVISIONS

Confidentiality
Article 18
1
The applicant may indicate which information submitted under this Regulation he wishes to be treated as confidential on the ground that its disclosure might significantly harm his competitive position. Verifiable reasons must be given in such cases.
2
The appropriate authority shall determine, after consultation with the applicant, which information other than that specified in paragraph 3 should be kept confidential and shall inform the applicant of its decision.
3
The following information shall not be considered confidential:
a
name and composition of the feed additive and, where appropriate, indication of the production strain;
b
physico-chemical and biological characteristics of the feed additive;
c
the conclusions of the study results on effects of the feed additive on human and animal health and on the environment;
d
the conclusions of the study results on effects of the feed additive on the characteristics of animal products and its nutritional properties;
e
methods for detection and identification of the feed additive and, where applicable, monitoring requirements and a summary of the results of the monitoring.
4
The Food Safety Authority must, on request, supply the appropriate authority with all information in its possession, including any identified as confidential pursuant to paragraph 2.
5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6
The appropriate authority and the Food Safety Authority must keep confidential all the information identified as confidential under paragraph 2 except where it is appropriate for such information to be made public in order to protect human health, animal health or the environment.
7
If an applicant withdraws or has withdrawn an application, the appropriate authority and the Food Safety Authority must respect the confidentiality of commercial and industrial information, including research and development information, as well as information on which the appropriate authority and the applicant disagree as to its confidentiality.
Words in Art. 18(2) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 26(a); 2020 c. 1, Sch. 5 para. 1(1)
Art. 18(4) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 26(b); 2020 c. 1, Sch. 5 para. 1(1)
Art. 18(5) omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 26(c); 2020 c. 1, Sch. 5 para. 1(1)
Art. 18(6) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 26(d); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 18(7) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 26(e)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 18(7) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 26(e)(ii); 2020 c. 1, Sch. 5 para. 1(1)