Table 1.

Comparison of processing parameters of the approved method in the legislation (Commission Regulation (EU) No 142/2011) and the alternative methods (submitted by the applicant in 2017 and 2020)

	Methods and their parameters
	Commission Regulation (EU) No 142/2011 Section 2 D, Chapter IV, Annex IV				RepCat® process, 2017				RepCat® process 2020
Process	pH	T	t	p	pH	T	t	p	pH	T	t	p
Pressure sterilisation a	n.s.	133	20	3 bar	n.s.	133	20	3 bar	n.s.	133	20	3 bar
Removal of insoluble impurities b	n.s.	n.s.	n.s.	n.s.	n.s.	n.s.	n.s.	n.s.	n.s.	n.s.	n.s.	n.s.
Esterification c	< 1d	72	≥ 120e	n.s.	n.s.	≥ 220	≥ 30h	≥ 80 bar	n.s.	≥ 200	≥ 15i	≥ 70 bar
Transesterification c	14f	35–50	≥ 15g	n.s.
Vacuum distillation	n.s.	150	n.s.	n.s.	n.s.	≥ 150	n.s.	≤ 10 mbar	n.s.	≥ 150	n.s.	≤ 10 mbar

n.s: not specified; T: temperature in centigrade; t: time in minutes; p: pressure in bar or mbar as indicated.

^aAccording to method 1 as specified in Commission Regulation (EU) No 142/2011.

^bTo obtain cleaned raw material with solid content < 0.15% w/w.

^cFor the RepCat^® method, esterification and transesterification are combined into a single step.

^dBy addition of sulfuric acid or equivalent acid.

^eMixed intensely.

^fBy addition of potassium hydroxide or an equivalent base.

^gCarried out twice using a new base solution.

^hMixing with addition of methanol to 15% w/w.

ⁱMixing with addition of methanol to 10–15% w/w and traces of MgO as catalyst.