ISO 21469: is it really necessary?

Some of you may have read details of the standard ISO 21469 which covers ‘Safety of Machinery – Lubricants with Incidental Product Contact – Hygiene requirements,’ and may wonder why the food industry or the lubricants industry need yet another standard to which they should adhere.

When this standard was introduced to the ELGI (European Lubricating Grease Institute), it has to be said it was less than well received by grease manufacturers from Europe and beyond, who thought it had no added value over ISO 9000 and other regulations and standards in existence.

The standard produced by the International Organisation for Standards (ISO) was said to be poorly constructed and added nothing to the safety or quality of the lubricants produced for the food industry. In fact, some delegates thought that many of the points were already covered by ISO 9000, HACCP or certainly by REACH.

Concern was expressed that the introduction of this standard by the large multinational companies would force smaller businesses to adopt it as a marketing tool even if it added no benefit to the company or customer. It was even suggested that it may be used as a ploy to force small companies out of the market place.

The costs of registering for ISO 21469 were also very vague. Figures were thrown in but no concrete quotation was available at the time, so we must wait and see. You can be sure it will not be cheap, especially since auditing companies are not flocking to offer registration.

An extract from the unapproved minutes of the ELGI food grade lubricants working group, consisting of 35 members, from January 2008 states:

“Although not shared by all members, the general feeling of the working group is that a certification programme based on ISO 21469 is not required since many of the items covered by such a programme are covered by other programmes and regulations. Examples are quality management systems such as ISO 9000 and regulations such as REACH.

All members agreed that it is the market that will ultimately determine if a certification program based on ISO 21469 will be important in the future. In the meantime, the working group will identify the ISO committee that oversees ISO 21469 and determine the mechanism for initiating modifications to the standard. Members that are interested in doing so also agreed to determine whether or not their ISO 9000 registrars would be interested in creating an H1 registration program or an ISO 21469 certification program.”

At a meeting of the NLGI (National Lubricating Grease Institute) in Williamsburg, Virginia, USA on 8 June 2008, the following was reported in the unconfirmed minutes:

“As there appeared to be some confusion and discontent amongst members present regarding the ISO 21469 within the members present, Mr Mistry asked everyone for a show of hands on ‘for and against’ the standard – 21 present were ‘ against’ and one ‘for’. Clearly there are concerns regarding the standard.”

Hardly a resounding endorsement!

The standard does not insist on product testing but simply says ‘when available’. Nor does it define any useful new criteria beyond the already existing and well respected H1 system introduced by the USDA several years ago, continued most successfully by NSF, and recently joined by European company InS Services.

InS is a private company formed to offer grease makers an alternative place to register. Evaluation is based on the original USDA system and ingredients must meet the requirements of FDA 21CFR.178.3570, the well-established, tried and tested list used by the USDA for many years.

Staff at InS have vast experience in the lubrication industry and a team of chemists who are happy to assist in locating raw materials and offer advice on formulation changes where products may fail to reach the strict criteria.

H1 is accepted around the world by food manufacturers as the benchmark for food safe lubricants. It is true that this is an American standard but it has been adopted by grease makers in most countries. A look at the NSF and InS registers will show that in just about every country where food is processed, a grease manufacturer has registered an H1 product.

Grease manufacturers have studied ISO 21469 in detail and many feel it can be totally complied with simply with a desktop audit in conjunction with a company’s ISO 9000 auditors and registration of products to H1 standards with either NSF or InS. Talks with ISO specialist companies including UKAS (the United Kingdom Audit Service) would seem to confirm this.

UKAS have confirmed that as of February 2009, no company has been granted accreditation by them for auditing ISO 21469 and as far as they were then aware, no company had applied for such accreditation. This seems surprising for what we are led to believe is the future of food safety regulations.

It has been suggested that there is no European regulation governing the use or manufacture of food lubricants, but this is simply not so. Lubricants as chemicals were first regulated by dangerous substances directive 67/548/EEC and now by REACH regulations 1907/2006/EC which have been in force since 2007 but in a transitional phase for registration until July 2018. REACH requires a data dossier for substances according to tonnage.

Food regulations which are controlled by EFSA (the European Food Safety Agency) require data related to the food contact directives.

Another regulation of interest is Codex Alimentarius, which defines several principles of food hygiene, from primary production through to consumer.

As long ago as 1966, the mineral hydrocarbon in food regulations were introduced in the UK and stated:

“No person shall use or permit to be used any mineral hydrocarbon in the composition or preparation of any food;

No person shall sell, consign or deliver, or import into England and Wales, any food containing any mineral hydrocarbon.”

In the late 1980’s, this act seemed to be revived and many believe that this was responsible for the large increase in the market for synthetic hydrocarbons such as PAO and similar, not only in the UK but around the world.

These regulations are mandatory and by combining them, we have a much more reliable tool than ISO 21469.

If all the data required by REACH was made available then it would fit the minimal requirement for food contact, which is to have three negative mutagenicity studies to allow migration into food of up to 50mg/kg food.

It has been suggested that we should begin a European equivalent to H1 which will remove the need to follow the US system and eliminate the need for a new ISO standard by using information which is already approved by a European authority.

ITEC Consultancy, a French company, has already put together a proposal for offering a ‘European H1′ based on European regulation requirements using data generated in the REACH dossiers.

This proposal offers the advantage of being compliant with European regulations, whereas USDA standards are not.

It may be called ELUB1 and will apply to all lubricants with food contact, whether incidental or direct, and will apply to ingredients was well as finished products. Don’t be surprised to see this grade being offered in the near future for products complying with current EC regulations with already existing rules.

In the final analysis, as declared by the ELGI food grade lubricants working group, the decisions rest with the food manufacturers and their respective governments. In the meantime, we have H1 which so far seems to have never let us down. So let’s keep an eye on the market needs and not the needs of the ISO auditors, who it has been suggested would be the only group to gain an advantage from this new system.