A Guide to FDA’s LACF Requirements
Unlike most other food products, Low Acid Canned Foods (LACF) are subject to slightly different regulations under FSMA and FSVP.
Federal Regulations require commercial processors of shelf stable acidified foods and low-acid canned foods in a hermetically sealed container to be sold in the United States to register each establishment and file scheduled processes with the Food and Drug Administration for each product, product style, container size and type and processing method (21 CFR 108).
As defined by the FDA, a Low Acid Canned Food (LACF) product can be defined as “any food (other than alcoholic beverages) with a finished equilibrium pH greater than 4.6 and a water activity greater than 0.85, excluding tomatoes and tomato products having a finished equilibrium pH less than 4.7.”
Where a product may fall under LACF this may be a sticking point to successful export to the US, especially where there is no relationship between the manufacturer and the exporter (or the importer). In this case the following options are available:
- Obtain the FCE and Process SID from the manufacturer - this is the ideal case and should be pursued where possible. Where the FCE and Process SID cannot be obtained the product will not be able to be exported to the US.
- Agree with the manufacturer that they will ‘file’ for FCE and Process SID - this is a significant project, however if there is good sales potential for the exporter and the manufacturer then this is the preferred case. Primority can assist with this process.
- Obtain the Material Specification from the Manufacturer - where there is a good relationship with the manufacturer of the product, they will supply the product specification which will detail the pH and Aw of the product together with a CoA (Certificate of Analysis) which documents and verifies this.
- Determine LACF Requirements through Lab Testing - This can be carried out by an external laboratory, but this may be expensive if there is a large product range. This involves checking the pH and Aw (water activity) and obtaining a laboratory report. If the Aw is >=0.85 and the equilibrium pH is >4.6 then it is likely to be regulated under CFR 21 Part 113 (for LACF) and therefore will require an FCE and Process SID. In addition, if the product is NOT predominantly an acid food which contains only small amounts of low-acid food(s) and has a resultant pH that does not significantly differ from that of the predominantly acid food then the product will be regulated by CFR 21 Part 113 (for Naturally Acidified Foods).
- Determine LACF Requirements through In House Testing - This can be carried out in house using testing equipment, which will be much less expensive if there is a large product range. This involves checking the pH and Aw (water activity) and obtaining a laboratory report. If the Aw is >=0.85 and the equilibrium pH is > 4.6 then it is likely to be covered under LACF and therefore will require an FCE and Process SID.
- Live with the risk of import refusal - this could be costly in terms of the risk of product import refusal, detention, and delays. This approach is not recommended.
Note: There are additional requirements to LACF, namely that the Process SID filing with FDA must demonstrate using scientific methods implemented by a ‘Process Authority’ (an expert in thermal processing) that the process is effective in destroying Clostridium Botulinum organisms under worst case conditions.
Still Unsure if Your Product is LACF?
If you are unsure which regulation covers your product, or for a more detailed overview of all FDA compliance requirements please see our services page, or feel free to contact us for a friendly chat on how we can help using the contact form to the side of the page.
Below is the process flow for determining if a product falls under the LACF Final Rule. FDA also has a documented version of this at this link.