BRCGS Consumer Products Issue 5 Enhanced Hygienic Conditions: Does Section 7 Apply to You?

By Robert Low, Lead Management System Specialist and BRCGS Approved Trainer

Most consumer products sites will never need Section 7. A few absolutely will, and they will find out late if they do not ask the question early. Here is my plain English view of BRCGS Consumer Products Issue 5 enhanced hygienic conditions, how to decide whether they apply to you and what they ask of you if they do. It is my interpretation of the published standard, so check the official wording.

What Section 7 Is For

Some products are more vulnerable to microbes than others. The standard’s own example is a product like contact lens solution. If microorganisms can grow or survive in the product and that could harm the person using it, the site needs stricter controls over its people, premises, equipment and processes. Section 7 is that set of extra controls. It sits on top of sections 1 to 6, it does not replace them.

The Two Question Gate

You do not choose Section 7. The standard tells you whether you are in it, and the answer comes from two questions. Either one is enough.

Question one: does hygienic manufacture legislation apply? Is there a specific law about microbiological contamination in manufacture in the country where you make the product or the country you sell it into? Cosmetics regulations and medical device manufacturing rules are the examples given.

Question two: can your finished product support microbial growth or survival, in a way that could harm the consumer? Internal sanitary protection products are the example given. You answer this with your product risk assessment, the same documented assessment I covered in the HARA post.

If the answer to both is no, Section 7 does not apply, and you should be able to show the reasoning. If the answer to either is yes, the whole section does.

You Have to Show Your Working Before the Audit

This is the point I would highlight most. When your audit is being planned, the site is required to give its risk assessment evidence to the certification body. That means the decision cannot be a gut feeling. It needs a dated, documented assessment, by someone competent, that a stranger can read and follow. A site that makes wet, creamy, liquid or otherwise microbe friendly products and has never written that assessment down has a job to do.

What the Section Asks For

In broad terms, if Section 7 applies, expect to show the following.

• A risk assessment of where product is exposed, covering flow, segregation, air, drains and water.
• Controlled drains with pest protection and a way to stop flow from dirty areas to clean ones, plus air filtration and pressure checks where they are needed.
• Water that is treated, stored and monitored, and treatment systems that are designed and validated.
• Changing facilities, footwear control and hand washing at the entrance to the area.
• Cleaning that has been validated and re-validated when things change, with effectiveness checked and recorded.
• Protective clothing that is distinct, not worn outside the area and laundered under a validated process. Home laundering is not permitted for these sites.
• Tighter personal hygiene rules on hands, watches and jewellery.

My Model: The Gate, the Map, the Proof

The gate. Answer the two questions in writing, with the reasoning and the evidence.

The map. If you are in, mark on your site plan exactly which areas are enhanced hygiene areas, and how people, materials, waste and air move in and out of them.

The proof. For each requirement, ask what record would show it. Validation reports, air pressure logs, water test results and cleaning verification all need to exist before the audit, not be written for it.

Where Sites Get Caught Out

Common ones are no written assessment at all, assuming Section 7 is for food only, forgetting the visitor and contractor rules, and home laundering of clothing in a site that needs these controls. The other is deciding too late. The proof takes months to build, which is another reason to start early. My transition plan shows where it fits in the timeline.

If you are not sure which side of the gate you are on, that is a short, practical review I do remotely, and it is cheaper than finding out during audit planning.