<s>[INST] The next text is a question of a member of the European parliament:"Pursuant to Article 1(2)(e) of Regulation EC No258/97(1), foods and food ingredients consisting of or isolated from plants and obtained by traditional propagating or breeding practices and having a history of safe food use do not fall within the scope of that Regulation. Pursuant to Article 3(4) of the Regulation, asimplified notification procedure as set out in Article 5 of the Regulation applies to foods or food ingredients that are judged to be substantially equivalent to foods or food ingredients already authorised. The EU has authorised the placing on the market by the company Morinda of noni juice as a novel food. For other products produced from noni fruit, however, the basic possibility of their being regarded as substantially equivalent to the authorised juice has to date always been refused.  The costly authorisation procedure under the Regulation prevents small and medium-sized companies from introducing new natural products into the EU. In effect, this creates a monopoly for large groups, as only big companies have sufficient resources to carry out such procedures.  1.According to what criteria is """"""""having a history of safe food use"""""""" defined in this connection, and which institution decides whether a food or food ingredient has a history of safe food use?  2.What legal remedies are available to a distributor seeking to establish that a food or food ingredient has a history of safe food use?  3.What requirements are laid down by the Commission in respect of evidence that a food or food ingredient has a history of safe food use?  4.What legal remedies are available to a distributor where the competent national body referred to in Article 4(3) of the Regulation refuses to deliver on opinion declaring that a food or food ingredient is substantially equivalent to a food already authorised?  5.What is the basis for the EU working party's conclusion that only another juice may be regarded as substantially equivalent to authorised noni juice?    (1)OJ L 43, 14.2.1997, p. 1."
Analyze carefully the text and assign it to the most relevant policy area among those listed below. Do not explain your answer and return only a number.
Policy area numbers: 1 = Macroeconomics
2 = Civil Rights, Minority Issues and Civil Liberties
3 = Health
4 = Agriculture and Fisheries
5 = Labour, employment and pensions
6 = Education
7 = Environment
8 = Energy
9 = Immigration
10 = Transportation
12 = Law and Crime
13 = Social welfare
14 = Regional and Urban issues and Planning
15 = Banking, finance and domestic commerce issues
16 = Defence
17 = Space, science, technology, and communications issues
18 = Foreign trade
19 = International affairs and foreign aid
20 = Governance and government
21 = Public Lands, Water Management and Territorial Issues
23 = Culture and media
[/INST]. Answer = [4]. </s>
Pursuant to Article 1(2)(e) of Regulation EC No258/97(1), foods and food ingredients consisting of or isolated from plants and obtained by traditional propagating or breeding practices and having a history of safe food use do not fall within the scope of that Regulation. Pursuant to Article 3(4) of the Regulation, asimplified notification procedure as set out in Article 5 of the Regulation applies to foods or food ingredients that are judged to be substantially equivalent to foods or food ingredients already authorised. The EU has authorised the placing on the market by the company Morinda of noni juice as a novel food. For other products produced from noni fruit, however, the basic possibility of their being regarded as substantially equivalent to the authorised juice has to date always been refused.  The costly authorisation procedure under the Regulation prevents small and medium-sized companies from introducing new natural products into the EU. In effect, this creates a monopoly for large groups, as only big companies have sufficient resources to carry out such procedures.  1.According to what criteria is """"""""having a history of safe food use"""""""" defined in this connection, and which institution decides whether a food or food ingredient has a history of safe food use?  2.What legal remedies are available to a distributor seeking to establish that a food or food ingredient has a history of safe food use?  3.What requirements are laid down by the Commission in respect of evidence that a food or food ingredient has a history of safe food use?  4.What legal remedies are available to a distributor where the competent national body referred to in Article 4(3) of the Regulation refuses to deliver on opinion declaring that a food or food ingredient is substantially equivalent to a food already authorised?  5.What is the basis for the EU working party's conclusion that only another juice may be regarded as substantially equivalent to authorised noni juice?    (1)OJ L 43, 14.2.1997, p. 1.