Table 2.

Batch‐to‐batch analysis of the NF

Parameter	Specification	Batch results of six commercial lots
		20121124	20130425	20130827	20140408	20140410	20140728
Phlorotannin	90 ± 5%a	90.1	88.1	89.9	88.3	90.2	90.2
Antioxidant activity	> 85%	91.4	90.8	90.4	88.5	89.1	88.1
Moisture content	< 5%	1.8	3.2	4.7	3.2	2.5	2.6
Ash	< 5%	3.1	3.1	3.8	3.2	3.6	3.2
Insoluble substancesb	Negative	Negative	Negative	Negative	Negative	Negative	Negative
‘Foreign’ substancesc	Negative	Negative	Negative	Negative	Negative	Negative	Negative
Appearance	Brown powder	Conforms	Conforms	Conforms	Conforms	Conforms	Conforms
Unpleasant odour or taste	Negative	Negative	Negative	Negative	Negative	Negative	Negative
Viable cell count	< 3,000 CFU/g	0	0	0	0	0	0
Staphylococcus aureus	Negative	Negative	Negative	Negative	Negative	Negative	Negative
Moulds and yeasts	< 300 CFU/g	0	0	0	0	0	0
Coliformsd	Negative	Negative	Negative	Negative	Negative	Negative	Negative
Lead	< 3 mg/kg	1.32	1.82	2.81	1.53	1.52	1.67
Mercury	< 0.1 mg/kg	n.d.	n.d.	n.d.	n.d.	n.d.	n.d.
Cadmium	< 3 mg/kg	0.08	0.12	0.156	0.13	0.08	0.14
Arsenic	< 25 mg/kg	21.30	16.56	21.69	21.49	23.40	19.81
Iodine	< 650 mg/kg	168.4	174.9	281.6	218.9	240.2	226.9
Sieving size	> 60 mesh	> 60	> 60	> 60	> 60	> 60	> 60

CFU: colony forming unit; n.d.: not detected.

^aPhloroglucinol equivalent using anhydrous phloroglucinol standard (PGEQ).

^bOriginating from Ecklonia cava (e.g. non‐soluble cellulosic residues).

^cAny substance not originating from Ecklonia cava introduced erroneously during the manufacturing process.

^dColiform analysis covers Escherichia coli. Since no coliforms are present, the applicant considered that a specific method to distinguish E. coli from other coliforms is not necessary.