E-Liquid Manufacturing legislation

Good Morning ladies and gentlemen.

I've been reading up a bit about the new tobacco laws and legislation.

I've seen that there are going to be more strict manufacturing procedures for E-Liquids. We have a lot of local E-Liquid producers in our country and the standard protocol appears to be various standards of clean rooms and the like.

Does anyone have any accurate information or know where I can find some accurate information on what the new legislation will be and what will be expected with regards to the manufacturing process of E-liquid.

Is it perhaps in that 17 page document that was proposed earlier this year?

Thanks in advance.
S

Standards for manufacturing and importing of tobacco products and electronic delivery systems 7.

(1) No person shall manufacture for sale or import a tobacco product or electronic delivery system unless it complies with such standards as may be prescribed and has been tested in the prescribed manner and using prescribed methods.

(2) All relevant products must be imported through the places of entry in the Republic appointed or prescribed in terms of the Customs and Excise Act, 1964 (Act No 91 of 1964). and maybe detained for inspection by the relevant authorities.

(3) Any relevant product which does not comply with the prescribed standards may be destroy"

This is all that I was able to find but it isn't very specific.

@Spyro there is a place holder for “as required” which I assume will define later on

incredible_hullk said:

@Spyro there is a place holder for “as required” which I assume will define later on

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Yes.
It'll most likely be one of the ISO's - ISO9000 / ISO22000.

ISO is in the process of developing its international standard for e-juice. Once this has been finalised and published, SA will consider if there is any reason to not adopt the ISO standard as is for our own SA National Standard (SANS) for e-juice. If there is no reason, the ISO standard will most likely become our SANS.

That standard will prescribe what may or may not be in e-juice, along with permissible thresholds. The standard will also contain a prescribed testing method using prescribed apparatus. If the SANS is a voluntary standard, manufacturers have no obligation to comply with it. This is the case for most consumer products, whose voluntary standards reside under the SABS.

If, however, the standard is deemed a compulsory specification - which is overwhelmingly likely given that vaping is considered to have inherent health risks - then the standard resides under the National Regulator for Compulsory Specifications. All juices in our market will have to show compliance with the standard, either through testing locally or the provision of test certificates from an accredited lab overseas. Failure to show compliance may result in the confiscation/destruction of the product by the regulator.

Over and above compliance with the product standard, govt may require manufacturers to be certified to a quality management system, such as ISO 9001 (Quality Management) or ISO 14001 (Environmental Management). Although ISO 9001 is technically a standard, it is more commonly referred to as a system. The system prescribed would get down to the nuts and bolts of what ISO level cleanroom is required, what PPE and hygiene gear the workers must use, etc. The standard really only looks at the characteristics of the product itself, the system addresses/governs the environment in which the product is made. So it is possible that both will be required in order to access our market.

I would guess that if a system is prescribed, it would be ISO 22000: Food safety management. I can't see 9001 or 14001 being applied.

RichJB said:

I would guess that if a system is prescribed, it would be ISO 22000: Food safety management. I can't see 9001 or 14001 being applied.

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Agree with your summation.
It would be heavy on the juice manufacturers, though.

RichJB said:

ISO is in the process of developing its international standard for e-juice. Once this has been finalised and published, SA will consider if there is any reason to not adopt the ISO standard as is for our own SA National Standard (SANS) for e-juice. If there is no reason, the ISO standard will most likely become our SANS.

That standard will prescribe what may or may not be in e-juice, along with permissible thresholds. The standard will also contain a prescribed testing method using prescribed apparatus. If the SANS is a voluntary standard, manufacturers have no obligation to comply with it. This is the case for most consumer products, whose voluntary standards reside under the SABS.

If, however, the standard is deemed a compulsory specification - which is overwhelmingly likely given that vaping is considered to have inherent health risks - then the standard resides under the National Regulator for Compulsory Specifications. All juices in our market will have to show compliance with the standard, either through testing locally or the provision of test certificates from an accredited lab overseas. Failure to show compliance may result in the confiscation/destruction of the product by the regulator.

Over and above compliance with the product standard, govt may require manufacturers to be certified to a quality management system, such as ISO 9001 (Quality Management) or ISO 14001 (Environmental Management). Although ISO 9001 is technically a standard, it is more commonly referred to as a system. The system prescribed would get down to the nuts and bolts of what ISO level cleanroom is required, what PPE and hygiene gear the workers must use, etc. The standard really only looks at the characteristics of the product itself, the system addresses/governs the environment in which the product is made. So it is possible that both will be required in order to access our market.

I would guess that if a system is prescribed, it would be ISO 22000: Food safety management. I can't see 9001 or 14001 being applied.

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Thanks so much @RichJB !

aktorsyl said:

Agree with your summation.
It would be heavy on the juice manufacturers, though.

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Yeah, system certification isn't usually required of industry. It's a "nice to have" but things get heavy if it becomes compulsory. I think it will probably be a product standard and they'll leave it at that. As long as the juice is within the limits prescribed by the standard, that should suffice to ensure consumer safety.

RichJB said:

Yeah, system certification isn't usually required of industry. It's a "nice to have" but things get heavy if it becomes compulsory. I think it will probably be a product standard and they'll leave it at that. As long as the juice is within the limits prescribed by the standard, that should suffice to ensure consumer safety.

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Fantastic info, I'm writing up a little paper on the current industry in SA and it's potential future and you've helped me an absolute ton. I really can't thank you enough.

Stupid question, but how could this affect the DIY guys? Would the raw materials also be regulated in the same way?

Spyro said:

Fantastic info, I'm writing up a little paper on the current industry in SA and it's potential future and you've helped me an absolute ton. I really can't thank you enough.

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No problem. Just to be clear, I'm speculating here. But conformity assessment/standards/certification tends to work to a fairly consistent and pre-defined process. Whenever a new product or technology emerges, the lack of an international standard is problematic. To take juice as an example, there are differing views on whether DAAP should be allowed. And if so, how much. If countries are left to their own devices, you might have Russia allowing DAAP with no limits, the EU forbidding it entirely, the US allowing only a very small amount, and then 35 other countries each allowing differing amounts.

This now becomes a nightmare for juice manufacturers. Do they pick one market and formulate specifically for that market and any other markets which are more lenient? Do they try to target all markets and reformulate for the more strict markets? This becomes a barrier to trade. If a juice company has to reformulate in order to access certain markets, it increases the cost of doing business and serves as a disincentive to import/export.

If ISO publishes an international standard, it will be a consensus view of all the countries represented on the Technical Committee which develops that standard. Which could be upwards of 30 countries. So it should represent a good global norm which many countries, merely by participating in developing the standard, have essentially pre-approved.

Once that standard has been finalised, there will be gentle pressure on all countries to accept that standard as is. This is the ideal for conformity assessment and national standardisation bodies everywhere: to have products tested against one standard, once. So, as a manufacturer, you send your product to one lab for testing. If your product passes, it opens up a whole bunch of markets for you. You email your test certificate to the standards authority in the export market, they accept it, and you're good to go. It enables trade and cuts down the bureaucracy and trade barriers.

That said, countries can have valid reasons for amending the international standard. My understanding is that the international standard for solar panels doesn't have very stringent thresholds for hailstone damage. The SA highveld gets far more severe hailstorms than most overseas countries. So the SA govt decided that the ISO standard wasn't suitable. We took the ISO standard and added a stricter hailstone impact specification before adopting that as our national standard.

It has annoyed some overseas manufacturers because they now have to beef up their solar panel structure, and some would rather just not trade with SA than do the extra work to comply with our standard. But govt decided that was a less harmful outcome than accepting international panels which will crack and shatter with the first severe hailstorm we get. So it's sometimes a fine line between fitting in with the global norm and protecting our own consumers.

With juice, unlike with solar panels, I can't see any compelling reason why local conditions would require amendments to the international standard. So my sense is that govt will just accept the ISO standard as is.

Humbolt said:

Stupid question, but how could this affect the DIY guys? Would the raw materials also be regulated in the same way?

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They already are to a degree. The flavours we use are food industry flavours and many have already passed the testing and certification processes required for that sector. Cap, TFA and FW flavours, for example, have been certified as Generally Regarded As Safe (GRAS) by the FDA. Our govt would obviously accept the FDA certification, again due to "removing barriers to trade" obligations.

However, food industry testing doesn't test for inhalation, only ingestion. It doesn't help certifying diacetyl as safe to ingest if it has an entirely different effect on the lungs than it has on the stomach. Unfortunately there is no consensus yet on how safe flavouring chemicals need to be, which ones are safe, and which ones need to be prohibited. Maciej Goniewicz and a bunch of other researchers are doing the testing legwork on them now. Once they have amassed a database of which flavours have which harmful effects, I guess ISO will get on it and come up with international guidelines on prohibited chemicals in juice. It is often a tedious and lengthy process but it has to be done if one wants to be scientific about things.

Understood. All the constituents on their own are already basically taxed, so unless I am a commercial E-juice manufacturer then the legislation shouldn't affect me (much), I suppose?
This proposed legislation might see a big spike in DIY'ers.

Humbolt said:

This proposed legislation might see a big spike in DIY'ers.

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I think that “proposed legislation” is key here. We can speculate all we want but we won’t actully know what’s potting until after the current process of considering the public and private sector input runs its course. Our charming law makers may yet surprise us but I somehow doubt it.

Fingers crossed...

Humbolt said:

Understood. All the constituents on their own are already basically taxed, so unless I am a commercial E-juice manufacturer then the legislation shouldn't affect me (much), I suppose?
This proposed legislation might see a big spike in DIY'ers.

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Still need to see what they will do about concentrated nicotine. DIY might not be an easy way around.

Humbolt said:

This proposed legislation might see a big spike in DIY'ers.

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It certainly will in the US. Let's just say that Wayne is likely to pick up a few new subs in the SanFran area shortly.

Most countries don't seem to mind DIY. There isn't much PR value in combating it as it's difficult to regulate what people have at home, and then also DIY is about adults doing things in their own homes, not marketing to kids. That seems to be the big concern, the marketing to kids. It's also the area where politicians can trumpet their legislative achievements the most.

I think there are rocky times ahead for the US juice industry, and flavours in particular. Scott Gottlieb was initially ambivalent about flavours in juice. Now his tone has changed somewhat. This is part of an address he gave a few days ago:

As part of the comprehensive plan we announced last year, we’re advancing a process to regulate the nicotine levels in cigarettes to render them minimally or non-addictive.

If cigarettes can no longer induct and sustain addiction, then our analysis shows that overall smoking rates in this nation will sharply decline. And as a consequence, the generational impact -- in terms of life years gained -- is enormous.

At the same time, we’re taking steps to help foster new technology that may offer adult smokers alternatives to access to satisfying levels of nicotine, but without all the harmful effects of combustion. These products must be put through an appropriate series of regulatory gates. And this includes e-cigarettes.

That said, we know that a lot of kids are using e-cigs. And we’re deeply troubled by these trends.

If by opening a path for e-cigs to be an alternative for adult smokers, all we end up doing is hooking a new generation of kids on nicotine, we’ll have failed in our purpose. We’ll have swapped one public health tragedy for a new one.

I don’t intend to let that happen.

So, we’re taking aggressive steps to bring enforcement actions against those who sell e-cigs to kids. And we’re focusing on companies that market these products in ways that are meant to appeal to teenagers. And I’ve been clear to the e-cig industry that we’re going to hold them accountable at every turn.

The companies that market these products can’t expect to build a sustainable business model that lets large numbers of kids get hooked on their products. These e-cig companies have a chance to do something about it. The window is open.

But it won’t be open for very long.

They better step up and step up soon -- to address these trends along with us. So far, I must say, I’ve mostly been disappointed by the tepid response from companies that know that a meaningful portion of their sales are being derived from kids.

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Ouch.

So it is now 2020 - (forget lockdown I am asking in general) what are the rules regarding DIY or "Craft" e liquids now? Does one need a special license to sell them or is all fine as long as the ingredients meet the ISO standards here in South Africa?

Styleoptix said:

So it is now 2020 - (forget lockdown I am asking in general) what are the rules regarding DIY or "Craft" e liquids now? Does one need a special license to sell them or is all fine as long as the ingredients meet the ISO standards here in South Africa?

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Not only your ingredients, but also your manufacturing facility needs to meet the ISO standards. I am under correction here. We have a few manufacturers on the forum.

@Paulie
@Blends Of Distinction

Maybe you guys can answer the question.

It really depends on where and to who you intend on selling... If you're gonna sell in a private capacity then it's not likely that you'll face any issues but if you want to stock your product in a retail environment then you'll need to have your products prepared in an ISO certified facility. Most of the reputable vape shops won't consider stocking your product without it being commercially produced.

There are no manufacturing standards to abide by in our country at the moment.
However most of your top brands are operating in great facilities. We for instance manufacture (mix, label and bottle) in our own ISO7 cleanroom. We want to send out the very best quality not because we have to but because we want to

takatatak said:

It really depends on where and to who you intend on selling... If you're gonna sell in a private capacity then it's not likely that you'll face any issues but if you want to stock your product in a retail environment then you'll need to have your products prepared in an ISO certified facility. Most of the reputable vape shops won't consider stocking your product without it being commercially produced.

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Thank you - yes supplying to friends and family, I use ISO certified ingredients but do not have an ISO certified laboratory, it is a hobby.