What should a lubricant BSE/TSE statement say to a customer?

This answer covers the statement a lubricant maker or distributor sends to a food or pharmaceutical customer. It does not replace an EDQM certificate of suitability or the risk assessment a medicinal product's marketing authorisation holder makes, and it does not cover allergen, GMO, halal or kosher statements, which need their own evidence.

What do you need before writing a lubricant BSE/TSE statement?

Before writing a lubricant BSE/TSE statement, you need four things: the exact product list, the full raw material list for each product, a dated origin document from each supplier of a possibly animal-derived raw material, and the name of the rule the customer works under. Take the raw material list from the formulation record, not the safety data sheet, because a safety data sheet is built around hazards and may not show a non-hazardous animal-derived component. Ask the customer which sector the statement is for. A pharmaceutical customer works to the EMA note for guidance EMA/410/01 rev.3, which EMA lists as the current effective version, last updated on 29 June 2011 (EMA, 2011). A US food plant works under 21 CFR 189.5, which applies to human food (21 CFR 189.5, 2026). Write product names and grades exactly as they appear on the customer's purchase documents, so the statement covers what was bought and nothing else. Finally, choose a signer who can see the raw material records, usually the quality or regulatory manager, because the signature tells the customer that a person checked the evidence behind each line.

Which lubricant raw materials can be of animal origin?

In a lubricant, animal origin usually enters through fatty acid chemistry and wool: metal soap thickeners, fatty acid esters, glycerol and lanolin can all come from tallow or sheep wool. Mineral and synthetic hydrocarbon base oils are not animal products, so the question usually sits in the thickener and additives. In soap greases, common acids include stearic acid, 12-hydroxystearic acid and complexing acids such as tallow, and the soap is typically 10% to 20% of the grease (STLE, 2017). The EMA position paper on tallow derivatives names magnesium stearate, glycerol and polysorbates as examples (CPMP, 1997). EMA/410/01 rev.3 names lanolin and wool alcohols as wool derivatives (EMA/410/01 rev.3, 2011). Species matters too: the guideline counts cattle, sheep and goats as TSE-relevant animal species, while pigs and birds are not (EMA/410/01 rev.3, 2011).

The table below shows which raw materials to flag and what the supplier must confirm.

In a soap grease, flag the metal soap row first, because the soap is typically 10% to 20% of the grease and can be made from tallow fatty acids (STLE, 2017).

How do you write a BSE/TSE statement for a lubricant step by step?

You write a BSE/TSE statement for a lubricant by working from raw material evidence to a signed text, one product at a time. Use these four steps:

1. List each product by exact name and grade, and flag every raw material that could be of animal origin, using the raw material table above; in a soap grease, check the 10% to 20% soap portion first (STLE, 2017).

2. Get one dated origin document per flagged raw material from its supplier, stating species, starting material and process conditions, for example hydrolysis at not less than 200 °C for not less than 20 minutes under pressure (EMA/410/01 rev.3, 2011).

3. Cite the rule the customer named: section 6.4 or 6.7 of EMA/410/01 rev.3 for a pharmaceutical customer, or 21 CFR 189.5 for a US human food customer.

4. Write one line per product and raw material (origin, process, rule met), list items still pending with the supplier, and sign with name, role and date.

Step 4 is where a statement differs from a blanket letter. A line such as "contains no animal-derived materials" is true only if every raw material has a supplier document saying so. When a supplier answer is outstanding, say which raw material is pending and when the answer is expected, instead of signing a claim you cannot back. The same evidence-first approach applies to other compliance letters, set out in how to answer a REACH statement of compliance request.

What should you ask raw material suppliers before signing a BSE/TSE statement?

Before signing a lubricant BSE/TSE statement, ask each supplier of a flagged raw material six questions and keep the answers as dated documents. These questions follow what EMA/410/01 rev.3 uses to judge tallow and wool derivatives:

1. Which species does the material come from: cattle, sheep, goats, pigs, plants or a synthetic route?

2. What is the starting material, and for tallow, is it Category 3 material or equivalent? EMA/410/01 rev.3 states that tallow used to make tallow derivatives shall be Category 3 material or equivalent as defined in Regulation (EC) No 1774/2002, which was repealed by Regulation (EC) No 1069/2009, applying from 4 March 2011 (EMA/410/01 rev.3, 2011).

3. Which process made the derivative, at what temperature, for how long and under what pressure?

4. For lanolin, was the wool taken from live animals?

5. Does the material hold an EDQM certificate of suitability, and if so, its number?

6. Will the supplier tell you before it changes the source or process?

The answers to questions 3 and 4 decide most statements, because EMA/410/01 rev.3 treats tallow derivatives made under its listed conditions as compliant "irrespective of the geographical origin and the nature of the tissues" (EMA/410/01 rev.3, 2011). A supplier who answers only "BSE-free" has not answered question 3, so keep that raw material as pending.

What should a lubricant BSE/TSE statement say when a raw material is tallow-derived?

A lubricant BSE/TSE statement for a tallow-derived raw material should name the raw material, state that it comes from tallow, give the process and its conditions, and cite the section of the rule those conditions meet. EMA/410/01 rev.3 addresses lubricants directly: "Other materials such as cleaning agents, softeners and lubricants that come into contact with the medicinal product during its routine manufacture or in the finishing stage or in the primary packaging are considered in compliance with this Note for Guidance if they are tallow derivatives prepared using the rigorous physicochemical processes as described in section 6." (EMA/410/01 rev.3, 2011). The examples in section 6.4 are trans-esterification or hydrolysis at not less than 200 °C for not less than 20 minutes under pressure, and saponification with 12 M NaOH at not less than 95 °C for not less than 3 hours (batch) or not less than 140 °C under pressure for not less than 8 minutes (continuous), or equivalent, and distillation at 200 °C (EMA/410/01 rev.3, 2011). An illustrative line: "The lithium stearate in Grease A is made from bovine tallow fatty acids by hydrolysis at not less than 200 °C for not less than 20 minutes under pressure (supplier letter, date), and meets section 6.4 of EMA/410/01 rev.3." If the supplier used other conditions, the guideline says the derivative "must demonstrate compliance", so mark it pending. For a US food customer, 21 CFR 189.5 excludes tallow derivatives from prohibited cattle materials (21 CFR 189.5, 2026).

How do you check a lubricant BSE/TSE statement before it goes out?

You check a lubricant BSE/TSE statement before it goes out by testing every line against a supplier document and the customer's rule. The table below decides whether the draft can be signed or needs another round with suppliers.

Start with the first row: one raw material without a supplier document makes a whole-product claim unsupported. Then check the tallow row: a supplier letter that says "BSE-free" without temperature, time and pressure cannot show that the derivative meets section 6.4 of EMA/410/01 rev.3, so the statement should name that raw material as pending rather than compliant. Run the same check again whenever a raw material supplier, a starting material or a process changes, and reissue the statement with a new date, so the customer's file always matches the current formulation. In Lubinpla, the technical inquiry reply task states only the facts confirmed in the raw material documents on record and leaves each unconfirmed item with the path to confirm it.

Common mistakes in lubricant BSE/TSE statements

The mistake to avoid first in a lubricant BSE/TSE statement is a blanket claim that the products cannot transmit BSE/TSE, with no raw material basis and no rule cited. One maker's published 2017 statement, for example, confirms that its products cannot transmit BSE/TSE and lists lanolin and animal fats among excluded materials, but names no guideline (ROCOL, 2017). That format answers a food customer's first question; a pharmaceutical customer usually needs the process conditions and the guideline section as well. Other mistakes are easy to avoid:

• Citing Regulation (EC) No 999/2001 to a pharmaceutical customer: EMA/410/01 rev.3 notes that the specified risk material principle of that regulation does not apply to medicinal products (EMA/410/01 rev.3, 2011).

• Treating a synthetic ester as animal-free by default: fatty acid esters can be tallow derivatives made by trans-esterification (EMA/410/01 rev.3, 2011).

• Counting pig-derived fat as a TSE risk: pigs are not TSE-relevant animal species under the guideline (EMA/410/01 rev.3, 2011), though a halal or kosher customer may still need to know.

• Leaving the statement undated, so nobody knows when to reissue it after a supplier or process change.