Fixed Oil Products - Oral

What this guide covers

this reference is intended to serve as a guide to industry for the preparation of product documentation for supplement market authorization.

• this reference only covers naturally-occurring fatty acids in each fixed oil, including concentrated oils, but excludes fixed oils spiked with additional fatty acids.

• Essential/volatile oil preparations (e.g. those prepared by distillation) are not within the scope of this reference.

• Hydrogenated oils and partially hydrogenated oils are not within the scope of this reference.

• this reference may be used to support single ingredient or multi-ingredient products containing any active ingredient from Table 1.

Who does this guide cover?

Adults 18 years and older

How is it taken?

Oral

Which forms are covered?

this reference excludes foods or food-like dosage forms as indicated in the Compendium of references Guidance Document.

Although delayed release dosage forms are usually not supported by source authority's references, this reference includes ‘Capsule, soft, enteric-coated’ which is commonly used for products containing marine oils.

Quantities

Refer to Tables 2 and 3.

References: source authority 2023; Zielinska et al. 2017; Quinn et al. 2010; Yang et al. 1999; Leventhal et al. 1994. ¹The amount of fixed oils can also be represented in volumetric amount (i.e., mL) based on the density information listed in Appendix 1. *The total amount of a specific fatty acid (e.g., LA) in the product should meet the minimum dose as per Table 3 to support a claim from this table. It is not required that each oil meets the minimum amount of specific fatty acids if the total amount of a fatty acid in the finished product meets it.

¹For products making claims from this table, the potencies must be indicated for the relevant fatty acid constituents. ²References: source authority 2023; EFSA 2010a; EFSA 2010b; EFSA 2009; Simopolous 2007; IOM 2006; IOM 2002; Simopolous 1999. ³Docosapentaenoic acid (DPA) can be included in the claim if the potency information for this constituent is also listed. ⁴For Schizochytrium oil, the specific quantity listed in Table 2 for the cognitive/brain health/function applies (i.e., DHA: 200 - 2000 mg per day).

Notes:

• The above uses can be combined on the product label (e.g. Helps reduce triglycerides and maintain cardiovascular health).

• The terms ‘Helps’ or ‘Helps to’ can be used interchangeably on the label.

• The following potency information is considered as additional information and can be included on the label: XX% or mg total omega-3 (or omega-6) fatty acids.

How is it used?

The reference does not require an additional label statement in this section. This does not establish an absence of risk.

How long is it used?

The reference does not require an additional label statement in this section. This does not establish an absence of risk.

Warnings and precautions

Products containing Hemp seed oil, Sea buckthorn seed oil, Krill oil, Blackcurrant seed oil and/or Squid oil

Ask a healthcare professional before use if you are pregnant or breastfeeding.

Products containing fish oil

Pain of rheumatoid arthritis

Ask a healthcare professional if symptoms worsen.

Healthy mood balance

Ask a healthcare professional before use if you have psychological disorders such as anxiety or depression.

When should it be avoided?

No statements required.

Possible side effects

Products containing Krill oil and/or Squid oil

Stop use if hypersensitivity/allergy occurs [Source note 6].

Storage

Must be established in accordance with the requirements described in the applicable product regulations.

Products containing Schizochytrium oil, False flax oil, Hemp seed oil, Cod liver oil, Fish oil, Sea buckthorn seed oil, Krill oil, Flaxseed oil, Black current seed oil, Chia seed oil, Seal oil and Squid Oil except those encapsulated

Refrigerate after opening [Source note 7].

All products (information for industry; not for labelling)

To be packaged in airtight container, protected from light [Source note 8].

Conditions for combined preparations

• A use or purpose statement is only acceptable if at least one active ingredient/potency constituent associated with that statement is present at a dose at or above the minimum daily dose listed in Tables 2 and 3.

• active ingredients which do not meet the minimum daily dose for a use or purpose statement will be considered as acceptable complementary active ingredients in product formulations.

• All active ingredients included in this reference may be combined with the following restrictions:

  • The combined maximum daily dose of oils in a product must not exceed 15.0 g per day [Source note 4]. Maximum daily doses for individual active ingredient as per Table 2 apply.

  • The combined maximum daily dose of EPA+DHA in a single product must not exceed 5,000 mg for 18 years and older per day [Source note 5].

Appendix I

*When only a single value was found in the evidence, a variation of +/- 0.003 g/mL was applied to allow for potential variability. At least one of the following references was used to support density ranges: Moovendhan 2023; Turck et al. 2021; Purnamayati et al. 2019; Uzunova et al. 2019; Delgado-et al. 2018; Petcu et al. 2016; Lee et al. 2014; Edwin et al. 2013; Firestone 2013; Manisha and Sharma 2011; Zhang et al. 2011; Alamu et al. 2010; Budavari 1996; Subrahmanyam et al. 1994; Kyte R.M. 1956.