Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue No. 29 - Evidence - October 4, 2017
OTTAWA, Wednesday, October 4, 2017
The Standing Senate Committee on Social Affairs, Science and Technology met this day at 4:14 p.m. to study Bill S-214, An Act to amend the Food and Drugs Act (cruelty-free cosmetics).
Senator Kelvin Kenneth Ogilvie (Chair) in the chair.
[Translation]
The Chair: Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.
[English]
I’m Kelvin Ogilvie from Nova Scotia, chair of the committee, and I’m going to invite my colleagues to introduce themselves, starting on my left.
Senator Eggleton: Art Eggleton, senator from Toronto, deputy chair of the committee.
Senator Dyck: Lillian Dyck from Saskatchewan.
Senator Hartling: Nancy Hartling, New Brunswick.
[Translation]
Senator Petitclerc: Chantal Petitclerc from Quebec.
Senator Cormier: René Cormier from New Brunswick.
Senator Mégie: Marie-Françoise Mégie from Quebec.
[English]
Senator Stewart Olsen: Carolyn Stewart Olsen, New Brunswick.
Senator Seidman: Judith Seidman, Montreal, Quebec.
The Chair: Thank you, colleagues. I remind us that we are here to continue our study of Bill S-214, An Act to amend the Food and Drugs Act (cruelty-free cosmetics).
In our first panel, we recognize the Cosmetics Alliance Canada: Darren Praznik, President and CEO; and Laura Gomez, Legal Counsel. I will invite Mr. Praznik to make his presentation. We will follow that with questions, as usual. Please proceed.
Darren Praznik, President and Chief Executive Officer, Cosmetics Alliance Canada: Thank you very much, Mr. Chair. It’s a pleasure for us to be here to have this opportunity to speak on this particular piece of legislation.
My colleague, who is our counsel, is not here because we’re intending to throw out all kinds of roadblocks and fight legal issues. We brought her along because she has worked very much on the specific details around this bill, some of which give us some concern that we think require some amendments.
I want to start off by saying that our association is not opposed to the general principle that this bill is trying to put into place. In fact, in our industry, animal testing with respect to finished cosmetic products, which is what our companies produce, has virtually been eliminated. I believe Senator Stewart Olsen referenced that in her remarks. We use the number that probably over 99 per cent of new products in our category that come to the market do not involve animal testing in any way whatsoever.
I’ll get back to where that little teeny piece is at the end, as well as some of the issues we want to bring to your attention.
The document I have put in front of you today is the opening remarks. I’m not going to read this. In another life, I had the opportunity to serve as a health minister and a member of the Manitoba legislature. I’ve been on that side of the committee, and I know it’s not the most effective means to communicate with a committee.
However, I think it highlights some information you may want by way of background: Who we are as an association and what are the products that we represent. There is some background with respect to animal testing in our industry. I would just have you note that some of the references that have been made to the use of rabbits and other things in terms of testing finished products are long out of play; things like the Draize Test aren’t used anymore and haven’t been used for decades in terms of most of the world. And there is no need to use them.
I wanted to make sure you had that background.
If I may, from my past legislative experience, there’s a lot of work that has been put into this concept of how we recognize a ban on animal testing in legislation. I want to commit that my association has been that we’re very much in support of recognizing in some way.
The issues I raise with you are with respect to the complexities of doing it. It may seem very simple on the surface, but there are a host of complexities that have to be addressed, some of them by amendment. We’ve had an opportunity to work with the sponsoring senator — in fact, we even met today — with some further comments on amendments.
So I think this is the beginning of a process to see if we can find a piece of legislation that would be able to be passed by all members of Parliament and livable by all stakeholders. We’re very much committed to that.
I’ve included in your package of information a little chart. It’s an advertisement we’ve used in support of the self-care framework. I wanted to give you a range of the products covered by the definition of “cosmetics.” They’re not just beauty products, as sometimes has been referred to. If you’re going to impose some restriction on a group of products, you have to follow the definition. The definition of “cosmetics” is very broad in Canada. We don’t cover this area, but that definition can even include some animal veterinary products too. It’s very broad.
What I wanted to illustrate with this chart is the breadth of that product, but also under Canada’s Food and Drugs Act, any one of these products today can be defined either as a cosmetic, a drug or a natural health product. So one of the real practical problems is a lipstick. Depending on whether it has an SPF claim and the active ingredients, it could be covered by one of three sets of regulations, as could a shampoo, as could a toothpaste. It’s not like we’re easily going into the Food and Drugs Act to say we can pull out one particular group. I think the senator has tried to recognize that with some of this bill, but it does create some issues.
Each of those regulations has different requirements. For example, if this became law and it was breached today, the lipstick that was a drug would have a $5 million penalty for that breach, but the natural health product or the cosmetic would have only a $5,000 penalty for that breach.
Why this becomes important is that we have been asking for a decade to have this whole regime fixed, and Health Canada is now in the middle of a major reform called the self-care products reform framework. They’ve had massive consultations across the country and they are trying to develop a new scheme that will take into account all of these products under one regulatory house, or one regulatory framework.
Currently, in fact, these products are regulated by two different branches of Health Canada. We notice the speakers that you have coming from Health Canada are only from one of those branches and aren’t even the branch that’s in charge of the reform. So what we ask — and we can’t speak for Health Canada, nor do we yet know what their scheme will look like — is that whatever will come out of this process has to fit within that self-care framework, because it is probably a once-in-a-lifetime reform in these products and we wouldn’t want to have unintended consequences. We would suggest that needs to be incorporated into the thinking around this bill to see how it would fit.
The second issue we raise with you here, with the breadth of the products, takes us to our other issue. Whether it is a lipstick, shampoo, toothpaste or moisturizing cream, they overlap with a lot of other regulated products. It can be the colourants in a lipstick with paints and other colours that they may share, ingredients that go into a shampoo that are shared with products used for cleansers or disinfectants, or a moisturizing cream that has many of the same components of a medicated cream.
The reality for our industry is that there are very few ingredients that are specific to cosmetics. The ingredients that we use come out of a vast array of ingredients used by a host of other regulated products. So if a bill touches upon the purpose, intent of how that product or ingredient is used, what does that do? How does that fit in that particular framework? Our concern going forward is not with testing on finished products. We don’t do that. We also recognize this bill is not intended to affect what’s happened in the past but only in the future. There are not a lot of new ingredients out there, but every now and again, there are. An area where our industry is very short of potential new ingredients is preservatives, antimicrobials. These are ingredients that keep the product safe, prevent infection, prevent microbes from being passed on. It’s a very small palate.
If one were to have a new antimicrobial developed in the future, it would be used in a host of products, pharmaceuticals, cosmetics, potentially drugs, foods. The question is: If it were approved requiring regulators, requiring some toxicological points for which there were not animal alternatives, how would that be treated? Would that particular ingredient be allowed to be used in a food, in a pharmaceutical, but not in a cosmetic when you in fact wouldn’t add one further animal required for testing?
So it is an issue. It’s less than that 0.001 per cent that gives us some concern. It’s an area we by and large don’t control because we usually purchase our ingredients from suppliers who are producing and testing ingredients for a large marketplace. Despite people thinking cosmetics is a big industry, we are a very small purchaser among all those ingredients. You don’t take a lot of ingredients, in terms of volume, to go into those products.
We are also concerned about the way this bill would be structured because there are other federally and provincially mandated legislative regimes that require testing. The Canadian Environmental Protection Act is now reviewing some 23,000 substances, of which at least 1,000 are used in cosmetics, are being reviewed for human health and the environment. They may require testing that may require toxicological end points for which there is no non-animal test available.
The question becomes: How does that interact with this, as well as workplace safety and health legislation? We are supportive of where this is going, but we have a lot of issues around some of these details and that very small per cent, and we wouldn’t want to see this result in some absurd regulatory requirements at the end of the day because we didn’t address those details.
The Chair: Thank you very much. I will open the floor up to questions. I will offer the first ones to Senator Stewart Olsen, the sponsor, and to Senator Dyck, the critic.
Senator Stewart Olsen: If I may, I’ll go last.
Senator Dyck: Thank you for your presentation, the information that you’ve provided to us and the complexity with regard to categorizing different personal care products.
You mentioned that Health Canada is looking at a self-care products reform. Are you aware that in the States there’s also a similar initiative whereby there’s an bill before Congress on personal care products as well, with the main focus being safety? You mentioned safety a little bit, but there have been some recent cases with the safety of, for example, sunscreens — I don’t know where sunscreens would fall under this categorization. Are they a cosmetic — where sunscreens have caused severe blistering and where lipsticks contain lead. What are your thoughts on safety versus the need for animal testing?
Mr. Praznik: Just to distinguish, with the testing that’s required for a finished product, there’s no need for animal testing related to those things that you’re proving. What becomes an issue is on the safety of ingredients. When cosmetic manufacturers put together a product, they would look at the profile that the supplier provides of the testing and the profile for the use of that ingredient to see how it fits in that product.
What’s really important is that products, by law in Canada, are required under the Food and Drugs Act to be safe; cosmetics, when used as required. In the case of the drug and NHP, they require some degree of pre-approval that has to be met to go to market. Health Canada, as the regulator, establishes the standards they want to ensure safety. So when it comes to meeting these toxicological end points, it’s the regulator who, at the end of the day, has to decide whether or not there’s sufficient data to demonstrate safety.
We believe products should be safe. We strive to ensure they’re safe. I’m aware of one sunscreen, for example, about a year and a half ago that was made without a preservative and they had an issue around contamination. It was a child sunscreen, and they had to come off the market for a while until they worked out the product.
So there are risks to human health if you don’t have the proper ingredients and safety in a product, and preservatives are a really important one.
Senator Dyck: Could you then comment on the balance between human safety versus animal testing? Because this is being driven by the fact that some animal testing is seen as cruel, yet there’s also the need to protect public consumers.
Mr. Praznik: That’s a fair question and a fair balance. I think what we’ve recognized, even those who have been proponents of this, is that there are certain areas around human safety and pharmaceuticals and foods, et cetera, where human health is very important and has outweighed that. Cosmetics have always been looked at as something frivolous and they are not, as you can see by these products. Cosmetics have been singled out as users of the same ingredients for this particular position.
But I think the real answer is, always has been and should continue to be a real effort to develop scientifically valid alternative methods to animal testing. That’s really where this has to go. Our industry, particularly in the European Union and in the United States with two institutes, did a lot of work to develop the alternatives that have allowed us not to require those tests anymore. The same kind of impetus is needed in other places as well.
What makes this odd is the ingredient palate that we’re talking about is shared with a host of other products and different types of product categories. But we’re saying, here, that we’re going to pick out one use from that same group and highlight it.
If this bill became law I would suggest there’s probably virtually no animal in Canada whose numbers would change one bit. It certainly didn’t in Europe, in the case of Great Britain, for example. I’m familiar with the numbers. The real effort has to be finding those alternatives for that general testing that goes on if we really want to reduce the numbers of animals used in testing.
Senator Eggleton: Thank you for being here, both of you. With respect to cosmetics, you say that animal testing is virtually non-existent in Canada. You go on to even give it a percentage: 99 per cent.
Mr. Praznik: Ninety-nine per cent, plus.
Senator Eggleton: Let me understand the rest of it, the 1 per cent. Is this largely the testing for pharmaceutical purposes, where you have an ingredient that you might be putting into a product?
Mr. Praznik: First, it is not needed for finished products. Second, the palate of ingredients we use is largely a well-known one. We have a lot of ingredients to work with or reformulate, so there’s no need for any new animal testing. That’s why we can say 99.9 per cent-plus, because where it is on those rare opportunities or circumstances where you have a new ingredient or a new use for an existing ingredient whose safety you have to now prove for that use, for the toxicological end points that the regulators will require, there may be no alternative to animal testing to do it.
But remember, that’s not necessarily being done by our industry. That’s being done by an ingredient supplier who is looking at that ingredient and saying, “If I can develop the safety portfolio, I’ll make it available for pharmaceuticals, for food and for other products,” and cosmetics would be one of those small users.
As drafted, what this legislation could do is say you can use that particularly preservative in a food because you would have the safety data for food for a pharmaceutical, but you couldn’t use the safety data that you already have — not relating to any animals — to use it in a cosmetic. So it’s that teeny part and again, we’re focused on things like preservatives, which are really important to product safety.
Senator Eggleton: So you’re saying if pharmaceutical testing is done, it will involve animals because that’s a requirement of Health Canada.
Mr. Praznik: It depends.
Senator Eggleton: So are you saying that if you’re going to take something from that test — some ingredient that you’ve put into a cosmetic — you shouldn’t be penalized for doing that and you shouldn’t be told that you can’t do that, because it has nothing to do with the cosmetic testing but with pharmaceutical testing instead?
Mr. Praznik: That’s right, but more precisely it will more likely be an ingredient something like a preservative that you would use in a pharmaceutical, cosmetic or food. It’s not likely to be an active pharmaceutical ingredient, although in Canada, things like sunscreens are classified as drugs or natural health products and not as cosmetics.
Senator Eggleton: I understand the problem you relayed here.
We’re told that 75 per cent of the cosmetics sold in this country come from the United States. How does that inventory get affected by the bill in its original form? We understand there might be some amendments, but we haven’t seen that.
Mr. Praznik: Our legal counsel, Laura, has prepared a number of amendments. We have some concerns with the way the bill is drafted and its application. But properly drafted it should apply to any product sold in Canada, imported or not. By the way, in Canada, we import about twice as much as we export, but under free trade we became very efficient so most of our manufacturers export anywhere from 70 to 98 per cent of their production. We’re a very integrated industry. In fact, our suppliers are very international and integrated. So it’s not like this kind of work is even being done in Canada in many places. It’s being done by a supplier for a world market in supplying ingredients.
Senator Eggleton: Does your organization represent some of the companies from which these products are imported from the United States?
Mr. Praznik: Yes. Most of our member companies export and import, et cetera.
Senator Eggleton: So animal testing is virtually non-existent in Canada, or at least 99 per cent-plus.
Mr. Praznik: I would say that is true for our industry around the world.
Senator Eggleton: You would relate that to the United States as well?
Mr. Praznik: I would say yes. It’s a very integrated industry. Again, our industry around the world has been generally supportive of the bans and legislation on eliminating animal testing. The only little piece that still comes up is this piece about new ingredients for general use. If it was not developed for a cosmetic, does the regulator say you can’t put that in a cosmetic? I know it’s safe, but I can’t use it because I can’t use it.
That’s the tiny piece that has given us concern with this type of legislation. It’s very small. That’s why I’m saying we’re generally supportive of this. I think if a lot of good brain power got around the table at the right time, including my colleagues from the Humane Society, Animal Alliance and others, with the right legal counsel, we could probably find a way to bridge those gaps.
Senator Stewart Olsen has been working with us; It needs that kind of effort. The one caveat I would put on it is the real key people who need to be in the room are Health Canada and the people working on the framework because they’re the ones who have to make it work.
Senator Eggleton: They’re in the room.
Mr. Praznik: It’s not the right branch today.
[Translation]
Senator Mégie: I’m going to continue along the same lines as Senator Eggleton, in relation to your comment that more than 90 per cent of products are no longer tested on animals. Does that mean that, when products are labelled as made in Canada or sold in Canada, we can be assured that they were not tested on animals? What about products from other countries? One witness told us that legislation prohibiting animal testing already exists. Could this bill ensure protection against the use of animal-tested products?
[English]
Mr. Praznik: First, understand that cosmetics is an international business. They tend to be manufactured in one or two locations for world markets. One can never guarantee what happens in other jurisdictions, but what we can control is what happens within our border. Where the use of animal testing data hits into the system is when you are bringing to market in Canada a product and you have to either provide safety data or be able to indicate that the product is safe. Whether it’s a cosmetic where you notify or it’s a cosmetic that’s a drug or NHP, there has to be safety data. If we are prohibiting or limiting the use of that data, you just can’t use it, so if something happened in another jurisdiction it’s of no value to bring that product into Canada.
The second part is cosmetics that are made in Canada and exported, and we are very supportive. We have some refinements on wording to make it clearer that on finished cosmetic products made in Canada we would be supportive of a ban on testing on those products in Canada. It isn’t being done now. That we can control.
There are some countries in this world that use animal testing on finished products, in essence on imported products, as a means to deal with trade matters. Quite frankly, we all should be encouraging them. Our industry is working internationally to get China to move away from that. But what we can control is what happens in Canada or how products come to market here and the data that’s required to support them.
[Translation]
Senator Mégie: I’m going to ask you another question. Since animal testing is hardly ever used in Canada anymore, would you go so far as to question the usefulness of this bill, given that it applies to such a small number of products?
[English]
Mr. Praznik: Yes, you could probably say this, but I’ll give you a reason why, and I think it would probably be supported by some of the folks and organizations that have supported this. If properly done, where we can all make this work with and we don’t create some absurdities in regulation, I think it sends a very symbolic message to the world to get on with the work generally about eliminating animal testing and developing alternatives, scientifically, to eliminate animal testing.It also sends a message to regulatory authorities that when those are developed and validated by regulators that they should be used as the method of approving safety.
There is no pressing urgency that we will save animals today in Canada because I don’t think there are any to save. What this will do is send a very symbolic message, so getting the details right and making sure we are not creating absurdities in our regulation is important. You can see the chart. It may look insurmountable, but it is not impossible to get this right. That is why that symbolism.
Senator Dean: Thank you for your presentation. We see your ministerial skills in full flight here; very impressive.
Back to the 1 per cent. We have heard from witnesses earlier that there are already available alternatives to animal testing. Could you comment on that?
In cases where that isn’t possible, there is an exemption under clause 18.2 where the minister can permit animal testing in prescribed circumstances. Is that not broad enough to cover your concerns? If so, is there a regulatory exemption approach that is a bit broader than this or could be tweaked to cover off your concern? Frankly, I look at this, and I do think this is surmountable when I look at the products.
First, we have been told there are alternatives to animal testing for the 1 per cent. Is that true or not?
Second, what is wrong with the exemption that we already have and the ministerial powers that are already in this bill?
Mr. Praznik: Thank you, senator. If I could refer you to the second page of the document I handed out. Under “Development of alternative methods to animal testing,” in the second paragraph of 2(b), I highlight some of the areas where alternatives have been developed.
It is not just developing it. Regulators have to accept it as being sufficient.
The next paragraph flags some of the areas where science has just not been able yet to produce an alternative to animal testing that will be sufficient to prove the toxicological point.
It is this area where you have a new ingredient and new use of an ingredient and there is no other way to prove safety to a regulator without that test. That is the area we are talking about. The ingredients we are particularly concerned about are things like preservatives because they are the ones where we have the short palate. You can see where we are short.
When it comes back to the provision you referenced, the trouble we have with that is it requires notice and a public hearing. We think the public hearing was probably supported by some because what company will ever ask for a public hearing and be attacked by a whole bunch of groups and go through all of that? It is probably not worth it.
If I may put on my old hat as a former health minister. It is always important when you draft legislation that there be a safety valve of some sort that a minister can trigger in the interest of public safety. We would suggest that in responsible legislation there be one. If it does happen, it could be around a preservative.
I will give you quick example a bit unrelated to animal testing. You are familiar with parabens. They have been attacked by many. They are a widely used preservative.
A few years ago companies started moving to another preservative called MI/MCI because it was viewed as safer than parabens. The trouble is that everyone moved into it, and it was discovered shortly thereafter that it was increasing skin sensitivity in 1, 2 per cent of the population, which is pretty high. I don’t remember the exact number. The result was regulators in Europe and Canada banned it in leave-on products, so people had to go back to parabens.
It comes back to the area of safety around it, and how does a minister have a safety valve? How does industry or a regulator operate when they know that this particular preservative is safe? They have seen the safety data, but they can’t look at it for what is defined as a cosmetic. How do you deal with that? That is that little area where we have to figure out a way to address it.
I appreciate others may think, “Do you create a back door for animal testing?” I can understand that argument, but we need to get all these parties together to say, “There is the line,” and figure out a way to ensure we can still meet that very rare public need versus making sure there isn’t a back door to the principle. That is the challenge, and we are committed to helping resolve that.
In context, I want to add that there are not a lot of new ingredients. There are not a lot of new things. We are always remixing and finding new ways, but it is the small time when it happens, particularly with something like preservatives, that it becomes important.
Our trouble with that provision is I don’t think it would work. How do we address this issue? That is the troubling part. I think we have to get some good minds, including those at Health Canada, in the room to figure out how to do it.
Senator Dean: Do you think the answer lies in 18.2?
Mr. Praznik: Well, there are different ways to do it. You could give the minister the power to allow an ingredient where they think it is important to public health and safety.
When I was minister, there was a seniors’ home in Manitoba that was falling apart. My only option was to pull their licence and send 40 people onto the street in 40 below in February because I had no power to intervene and do the right thing. I had to cajole the owners to do it. We amended the act to give that prerogative to the minister under certain circumstances.
Protecting public safety is part of the balance. Any time you are restricting how you use a product, you have to have some safety valve in there.
Senator Petitclerc: My question has been mostly answered. You framed it as the “backdoor effect.” The way I understand it and with everything that we have listened to, if we do have those tens of thousands of already tested chemicals and those successful businesses that have proven that you can do without animal testing, then as far as I understand it, we are not in the life-saving business. It is hard for me to understand how any testing is justified.
I heard you, but my fear is that by those exceptions, you feel — it is a big business. There may be overlaps or even partnerships, and some ingredients may be tested in a way that could be said that it is for drugs, but I don’t know. Maybe I am going on about a conspiracy theory. I want to hear you out on that. I know you talked about it a bit, but I feel it is a justified fear.
Mr. Praznik: Anytime when I was on that side of the table and there were difficult, tough, complex issues, if you can get all the parties together — my colleagues who are here from various organizations, Health Canada and lawyers in the room — you can usually figure out a way to make this work.
I don’t want to speak for anyone, but if I was on the other side and you put some exemption, does that get used to push the envelope? That is legitimate. On the other hand, you don’t want to prohibit a legitimate issue that needs to be resolved. You have to figure out a way to do it.
We have some thoughts on it, but, in fairness, more people should be in the room.
Getting back to the crux of your question, if you look at some of the kinds of products we use, these aren’t beauty products in just saying it is a lipstick or coloured cosmetics. “Cosmetics” in Canada includes a whole bunch of things, including shampoos. If you put a sunscreen in them, they become a drug or an HP, which would be protected. You are talking about sun protection, hygiene and all of these things.
Many of these products contain water. They can become bad and spread. There was a case in England a few years ago where someone was putting a product on a kid, and it kept reinfecting a wound, because there wasn’t a proper preservative. So this is a matter of health.
The area we get down to, and the exception makes the rule, to some degree, is the area where we have the least and shrinking palate of ingredients. And it isn’t just us but everyone. It is an essential part of most of these products that require a preservative. If you close the door to a new preservative, like we saw with MI/MCI, what do you do?
I appreciate the argument: Should you be opening the door to some new magic ingredient that makes us all look like we’re — I like to tell people I’m 85 and use great anti-aging products, but you wouldn’t believe me. I can see that balance, but on the other hand, how do you close the door? How do you as a committee say some day that we couldn’t use a good preservative in a product because it required an animal testing component, so we used a lesser preservative that might not be as safe?
Remember that preservatives are antimicrobials they are toxins that kill microbes. They have to be sufficient to kill a microbe and yet not harm the human using them.
The Chair: Mr. Praznik, we are going down this road a lot. The ultimate question is this: Is a cosmetic necessary to use an unsafe component? There are bigger issues than where you are going with this, so let’s move on.
Mr. Praznik: Yes.
Senator Raine: Thank you for giving us this information. My understanding is that there are already many products — as you said in your remarks, we have a history of safe use and have well-known safety profiles, and many products on the market.
We are really looking at this with regard to new ingredients in new products. What is driving the desire for new if the old one is working? Is it because it is perhaps more economical for the manufacturer —profit-driven — or is it a marketing-driven thing to say “new and improved” — gets rid of more wrinkles, et cetera?
If we are doing that for those reasons and step over the line to say we ought to test on animals, I’m not comfortable with that. What is driving the need for new cosmetic products?
Mr. Praznik: If you look at the history of cosmetics and fashion, they are new. I remember companies that make coloured cosmetics that don’t involve animal testing at all, and every year, at any given time, 16 or 20 per cent of their products are new. There are new colours for the season. That is the nature of this business. There will always be new products.
Any product you bring to the market is usually done using existing products; it won’t be covered by this. The concern gets to be regarding the rare occasions when you truly have some new ingredient or new use for an ingredient that you have to demonstrates to the regulator the safety. This isn’t because the industry is doing testing to make a better product. This is because governments require testing on these substances. Not only for the product that is going for market, but we have seen under CEPA, environmental effects of that product, and under workplace safety and health.
I understand your concern, but you will get a lot of new products every year, senator, and they will not involve animal testing or the need for it. But there is that small part where they may require testing under some other regulatory scheme.
The Chair: But, Mr. Praznik, isn’t the purpose of this bill to prevent that occurring when that product is named as a cosmetic?
Mr. Praznik: Please repeat that, senator. I want to make sure I understand what you are saying.
The Chair: Isn’t the purpose of this bill to say that you cannot order animal testing for that product that is going in to produce a cosmetic, if that is the driving force? You are arguing on behalf of the cosmetic industry. The drug industries are perfectly capable of handling themselves.
Mr. Praznik: What I am saying, Mr. Chair, is that we don’t need testing on a product; it is not required on a product.
The Chair: You were referring to a new component into a new product.
Mr. Praznik: And our obligation under the law today is to produce a safe product. Ingredients that are available to us that are widely used in other things, and if it is a new ingredient — because existing isn’t counted — you would be prohibiting us from using that.
The Chair: Exactly.
Mr. Praznik: Yes.
The Chair: Exactly. That is the purpose of this bill, isn’t it?
Mr. Praznik: Yes. And the difficulty we have is that the small area of —
The Chair: Exactly. You have been going around it very well, but I wanted to get back to the point so that the committee understands it. They may agree with you, but we need to get to the point.
Senator Raine: As a follow-up to that, if we include in the legislation ministerial discretion to override for that small number of cases, can we handle it that way?
Mr. Praznik: Could be. One would have to look at how that was worded. The current wording we don’t think would work.
Senator Stewart Olsen: Thank you for being here. I have to mention that this bill has been on the books for quite some time. Regarding some of these things, today was the first time that I have heard of them. I know efforts were made in the drafting of the bill to speak with all involved, including you and certainly the Humane Society. To say that wasn’t done and that people were not spoken with —
When you bring a new product to market, and you have that new ingredient in it, can you not work with the regulators to circumvent or ask for an exemption? I don’t understand. No legislation will ever be perfect. It is about as perfect as — we do our best, but you are going way into the future with “maybe, if, and.”
The European Union, which has moved into this for some years now — these same arguments were made. In fact, the European Union’s ban was challenged, and the challenge was defeated.
I am wondering why you think we have to do better or rewrite the legislation? I don’t quite understand. We have a derogation clause, so I am not sure where you are going.
Mr. Praznik: One word: clarity. People who will use this legislation, these amendments to the Food and Drugs Act, whether they be the people who have to administer them or the companies who have to apply and live by them, are entitled in legislation to be as clear as possible about what our intent is and what we are trying to do.
There are some other provisions in the way this is drafted that create some unclear situations. We had Laura do an analysis of things we discussed with you already that you may consider bringing it at a later stage.
Clarity is what’s important. You can’t say to bureaucrats that, “Our intent is to say, ’No use of animal testing data at all but maybe you can work something out.’”
With respect to Europe for a moment, there was a ruling that was restrictive to the use of data from outside the European Union. Europe struggles with knowing how to use data from other sources. It is still an issue that has not yet firmly been ruled on. It was not referenced in the decision of the judge advocate that people often talk about.
If we are going to do something, we are all trying to get to the same goal, why wouldn’t we want to do it right and have a piece of legislation that everyone can live with and that will survive a long time without creating difficulty? We owe that clarity to the people who have to live with it.
Senator Stewart Olsen: I disagree with you. I have faith in our bureaucrats, sir, that they are pretty smart and know what is going on.
In any case, thank you for your answer.
[Translation]
Senator Cormier: Picking up on your last comment, I’d like you to give some examples to help us better understand the bill’s lack of clarity. Could you give us specific examples?
[English]
Mr. Praznik: I would ask Laura Gomez to answer that. She has worked in that area.
Laura Gomez, Legal Counsel, Gowling WLG (Canada) LLP, Cosmetics Alliance Canada: In reviewing the bill with our client, we identified several legal concerns regarding the drafting of the bill. The first is with the definition of “cosmetic animal testing.” The definition refers to testing that is conducted for the purpose of developing or manufacturing cosmetics. As Darren discussed previously, this requires that you establish the intent of the testing at the time that testing is being conducted.
This has the potential to cause confusion, which relates to the clarity point, because cosmetics or cosmetic ingredients could be subject to animal testing in other jurisdictions to meet those legal requirements, to satisfy other regulatory requirements or substantiate the use for other types of products. So it’s clarifying that terminology in the actual definition of cosmetic animal testing and then redrafting for the prohibition to prohibit reliance on evidence from animal testing for that cosmetic. And what you would be trying to do is redraft that provision to remove the element of intent so that the prohibition relates to the action of relying on that information.
Another example would be referring to finished product cosmetics with respect to the ban on the activities being conducted in Canada, so it’s using that terminology.
There are also issues with respect to the clarity for who is responsible for compliance. Under the cosmetic regulations, it’s the manufacturer — and that’s a term that’s defined — who is responsible for submitting evidence of safety, and it’s the manufacturer or importer who is responsible for notifying of the sale of a new cosmetic product.
One of the provisions that we suggested is clarifying that the term “no import or manufacture be used” and that would provide additional clarity to the industry and also who is responsible for compliance, in light of the global supply chain for these products and in order to not include retailers or direct sellers who could possibly be implicated by the broad language.
There are also some provisions that limit the regulator’s discretion, which Darren mentioned before, and there are ways that could be clarified to allow, in certain cases where it’s necessary for the protection or promotion of public health or safety of the public, for the minister to have the discretion to permit certain actions.
The Chair: I think we have had a pretty good discussion of these issues and we have another opportunity to get other points of view on these very points. I want to remind us that the purpose of this bill is to deal with components that are aimed at developing a cosmetic, and it’s important for the committee to keep that in mind.
I would like to ask the committee: Are you prepared to invite two representatives of Health Canada to join us at the table for clause-by-clause consideration?
Hon. Senators: Agreed.
The Chair: Thank you very much.
I want to welcome our colleagues from Health Canada. I want to try to remind my colleagues that we are dealing with the bill itself. We are not trying to reform all of Health Canada’s classifications of all the different products that are out there. There are reasons for those classifications. That is not the issue for us.
The issue is whether this is a bill that has a purpose that, first of all, is important to us; and, second, that the bill does not create more problems or confusion than exists, that is, that the bill does move reasonably towards the objective of the bill itself.
We have our colleagues from Health Canada here. I think it’s best that we start clause-by-clause consideration, and at a point where testimony that you have heard is important to your interpretation of the clause, we ask for clarification at that point. I think it’s better to do it that way than to try to have Health Canada make a presentation to us. I think it’s more appropriate within the context and their purpose for being here.
Is that acceptable to you?
Senator Dyck: What do you see as their purpose for being here?
The Chair: To answer questions on specific issues in the bill.
Senator Dyck: I just wonder —
The Chair: It’s a private member’s bill, not a government bill.
Senator Dyck: Right. But I also wondered, since we were told that they’re considering a major overhaul themselves, whether they could give us an overview of that in relation to this bill. Is that not a relevant issue?
The Chair: I think we had better stick to the bill itself. We can’t predict what’s coming down the road and I suspect neither can they. They can tell us what they’re working on, but not where that’s going to go. So I think we’re going to have to make a decision on the bill itself. If there is something that is immediately relevant to the bill, I’m certain that that would be brought to our attention if in fact the question is asked.
With your agreement, I will begin the clause-by-clause procedure; is that agreed?
Hon. Senators: Agreed.
The Chair: Thank you. I will formally ask the actual question: Is it agreed that the committee proceed to clause-by-clause consideration of Bill S-214, An Act to amend the Food and Drugs Act (cruelty-free cosmetics)?
Hon. Senators: Agreed.
The Chair: That’s agreed. Thank you.
Shall the title stand postponed?
Hon. Senators: Agreed.
The Chair: That’s agreed.
Shall clause 1, which contains the short title, stand postponed?
Hon. Senators: Agreed.
The Chair: Agreed. Thank you.
Now we come to the actual bill itself, and I put the question: Shall clause 2 carry?
Senator Eggleton: I have a question of Health Canada staff regarding whether they have any comment on the definitions here as to whether, in terms of implementation of the act, this creates any difficulty for you to interpret these definitions.
Geoff Barrett, Director, Risk Management Bureau, Healthy Environments and Consumer Safety Branch, Health Canada: Thank you for the question and thank you for inviting us here today.
Specific to the definitions as they are outlined there, we have no specific comment or suggestion for how that might immediately impact our business. I agree that wherever we can provide further clarity, that certainly helps us farther down the road as we look to compliance, enforcement and engaging with stakeholders, but no further comments from me.
The Chair: Any further question on clause 2?
Shall clause 2 carry?
Hon. Senators: Agreed.
The Chair: Clause 2 has carried.
Shall clause 3 carry?
Senator Stewart Olsen: I have an amendment for the clause and I wanted to explain it briefly.
The initial bill banned animal testing immediately upon bringing into force of the bill. On looking at that, I felt that it was perhaps a bit onerous for the cosmetic companies, so I think the approach of the European Union is a good fit for Canada. They have done this. They’ve defended it and they have the most successful cosmetic industry and beauty market in the world.
Accordingly, I move that Bill S-214 be amended in clause 3, on page 1, by replacing lines 25 and 26 with the following:
“cosmetic animal testing conducted more than four years after the day on which this paragraph comes into force.”.
The Chair: Let’s be absolutely clear. I’ll speak for myself in this case: Do I understand that you feel that there may well be activities and testing in progress that are well under way, such that this is intended to ensure there’s no unintended consequence impacting circumstances that were set in motion before this bill being presented to Parliament?
Senator Stewart Olsen: That’s correct. Thank you.
Senator Eggleton: A question to the senator. Does the amendment or the clause as amended have any impact on imports?
Senator Stewart Olsen: It extends the period of time on imports. But as you heard from the testimony here today, there is almost no animal testing on cosmetics being imported today. Their only objections were for the future: What if this happens in the future? So it does not touch the products in the past or for the next four years. But in four years, we would expect the industry to have had time to adjust.
Senator Eggleton: Domestic or foreign?
Senator Stewart Olsen: That’s right.
Senator Eggleton: Can I ask Health Canada about the issue of components or ingredients that are taken from a pharmaceutical test? The pharmaceutical test does require animal testing. How would this section, as it’s now being amended, impact that situation?
Emily Contreras, Unit Head, Cosmetics, Risk Management Bureau, Healthy Environments and Consumer Safety Branch, Health Canada: I would say that it’s not so much the pharmaceutical test that we would be as concerned about as other requirements under different acts, such as the Canadian Environmental Protection Act and the New Substances Notification Regulations.
Mr. Barrett: Again, in our program we deal very much with a post-market regime for the cosmetics program. It is different from our colleagues in the other areas of Health Canada, pharmaceuticals or natural health products, where there is a pre-market verification and they need certain data and information that confirms the efficacy of the claim they’re making or concerns the safety with which to use that product.
For us, working in a post-market environment, we are really concerned with that end product and the requirement for the companies to be able to list those ingredients there. But to the extent of where that information came from in our current regime and how we would move forward, that would not factor into our decision as to whether the health or safety of that product is in question. I’m not sure if I’m answering your question.
The Chair: I think you need to clarify it a little more for the way the senator has asked the question. The way you put it would imply that you look at the list of them and that’s it. But in fact you go beyond that and you check the ingredients against what is known about those ingredients, do you not?
Mr. Barrett: That’s right. What we actually have is an administrative list. We call it our hot list. That is a list where Health Canada has reviewed a number of substances, and if those substances are prohibited and not allowed in cosmetics, we’ve done the science to make sure and verify why that’s the case. In other instances, if there are restrictions imposed, whether that is that they’re allowed but only in a certain amount, that is then posted on what we call our cosmetics hot list. We do a verification against that to make sure that that substance is safe. However, as it stands right now, we don’t look at where the science in determining that efficacy or safety comes from. So if that is now part of the requirement that would be made for cosmetics, we would need to be able to build into our compliance and enforcement approach a means by which to check or verify that.
Senator Eggleton: I’m not totally sure of what I’m hearing. This says that it prohibits the manufactured use of cosmetic animal testing and it’s amended to say, “after four years from the day of coming into effect.”
So a new product is developed in the cosmetic industry, and it happens to have an ingredient that was tested for other pharmaceutical purposes which required animal testing. Would you interpret this as meaning they couldn’t do it and they couldn’t take that pharmaceutical product, even though it had already been tested and was required to be tested for that purpose?
Mr. Barrett: With the way in which we interpreted it and the way in which we have read this, it would not be allowed for use in cosmetics, then, if it was identified for another purpose. That is how I read the text here.
Ms. Contreras: I would say that it’s not necessarily 16(d), but 18.1 that would address that.
Senator Eggleton: The use of the minister’s authorization, yes.
The Chair: Let us be clear: We would understand that, at the first glance, it would say this doesn’t meet the issue and if there were pushback from the industry in order to have that accepted, it would require the ministerial exemption that occurs later in the bill. Is that correct?
Ms. Contreras: Sorry, I don’t know if I’m working with the same version but in the version I have, 18.1 is, “no evidence derived from animal testing conducted after the coming into force of this,” which I guess is the part that may be submitted or used to establish the safety of a cosmetic. And then, yes.
The Chair: And then it could be overridden by a ministerial discretion given in the next part, correct?
Are we all clear on that? Thank you very much.
Senator Omidvar: My question is for Senator Stewart Olsen. I’m curious about the four years. Does that mirror the European Union experience?
Senator Stewart Olsen: Yes, it does.
Senator Petitclerc: I had exactly the same question. Thank you for the answer.
Senator Dyck: My question is for Senator Stewart Olsen.
Earlier on, when you introduced the bill at second reading, you were talking about the U.S.A. and that they were developing similar legislation.
Senator Stewart Olsen: Yes.
Senator Dyck: Have they done that, and would they have incorporated the same kinds of regulations that you have?
Senator Stewart Olsen: I understand there’s a similar bill. It’s pretty much at the same stage as this is before Congress. The world is actually moving this way. I would like Canada to be a leader or one of the leaders in North America on this issue but that’s a personal view. I’m pretty sure that is what’s going to be happening.
Senator Dyck: Would the clause we’re looking at now essentially prohibit sales of cosmetics in the U.S. if the U.S. used animal testing in the manufacture of any of their cosmetics?
Senator Stewart Olsen: I haven’t seen their legislation.
Senator Dyck: I mean this legislation.
Senator Stewart Olsen: Yes, if it was manufactured in the United States four years from now and it contained an ingredient that had been tested on animals, then no, it could not be sold here without a ministerial approval. For the cosmetics that are coming now, this has no impact.
Senator Raine: My question was already answered.
The Chair: I’m going to read the motion. It was moved by the Honourable Senator Stewart Olsen that Bill S-214 be amended in clause 3, on page 1, by replacing lines 25 and 26 with the following — shall I dispense?
Hon. Senators: Dispense.
The Chair: Are you ready for the question?
Hon. Senators: Question.
The Chair: Shall the amendment carry?
Hon. Senators: Agreed.
The Chair: The amendment is carried.
Shall clause 3, as amended, carry?
Hon. Senators: Agreed.
The Chair: Clause 3, as amended, has carried.
Shall clause 4 carry?
Senator Omidvar: I’m wondering if that four years has to come back in here as well.
Senator Stewart Olsen: That’s exactly why our legal —
Senator Omidvar: So there’s no knock-on effect on to other clauses?
Senator Stewart Olsen: In clause 5.
Senator Omidvar: We’re looking at clause 4.
The Chair: She’s saying it comes back in clause 5, but the legal counsel didn’t feel that it entered in clause 4. That was the answer.
Senator Omidvar: As long as you’re safe on that.
Senator Stewart Olsen: I trust legal.
The Chair: No comment. Sorry, minor irritation of the throat.
Senator Dyck: Would that mean that the cosmetic animal testing in Canada would cease after the bill comes into force, but we’re giving a break to the countries we’re importing them from?
Senator Stewart Olsen: No. Four years. I’m giving the industry the time to adjust.
The Chair: The answer is that it applies across the board, wherever.
Senator Dyck: You’re saying the animal testing is coming into effect in Canada immediately.
The Chair: But it says very clearly, “the cosmetic animal testing conducted more than four years after the day on which this paragraph comes into force.” That is intended to cover all sources.
Senator Stewart Olsen: Yes, it is.
Senator Dyck: Developed or manufactured.
The Chair: The sponsor says it’s intended to cover all sources.
Senator Eggleton: Does Health Canada see any challenges or difficulties in clause 4?
Mr. Barrett: No, I do not.
The Chair: Any further questions?
Are you ready for the question on clause 4?
Hon. Senators: Agreed.
The Chair: Shall clause 4 carry?
Hon. Senators: Agreed.
The Chair: Clause 4 has carried.
Shall clause 5 carry?
Senator Stewart Olsen: Yes. For the same reasons, I move that Bill S-214 be amended in clause 5, on page 2, by replacing lines 9 and 10 with the following:
“ing conducted more than four years after the day on which this section comes into force may be submitted or used to establish”.
The Chair: Is that clearly understood? Any question on this?
Senator Eggleton: I have a question. Are you just dealing with 18.1 or are you into the whole of clause 5?
Senator Stewart Olsen: In the whole of clause 5, yes.
Senator Eggleton: In that event, 18.2(2) says:
. . . . conduct public consultation before issuing an authorization under subsection 1 . . . .
What does that entail? What kind of public consultations? Is there a formula? Maybe Health Canada would know the answer to this. Is there a formula that you follow now when you conduct public consultation on this? Do you publish in the Canada Gazette or something? What does that mean?
Mr. Barrett: That’s correct. Often consultations are notified in the Canada Gazette for a period of 60 days unless otherwise stated to what that might be.
Senator Eggleton: That’s how you would interpret that clause. That’s fine.
Ms. Contreras: Let me add something. That is for regulatory consultations. If this would require a regulatory amendment, then that is the case but it’s not exactly clear.
Senator Stewart Olsen: I think it would, because it’s referring to animal testing for cosmetic purposes. That’s what the bill deals with but it would be up to the minister on the public consultations, I would think.
Senator Dean: Clause 18.2 wouldn’t be operable for the next four years in any event, would it?
The Chair: That’s correct.
It is moved by the Honourable Senator Stewart Olsen that Bill S-214 be amended in clause 5, on page 2, by replacing lines 9 and 10 with the following:
“ing conducted more than four years after the day on which this section comes into force may be submitted or used to establish”.
That’s the phrase that’s being inserted. Is it clearly understood by the committee? Are you ready for the question on the amendment?
Hon. Senators: Yes.
The Chair: The amendment has carried.
Shall clause 5, as amended, carry?
Hon. Senators: Agreed.
The Chair: Clause 5, as amended, has carried.
We’re back to clause 1. Shall clause 1, which contains the short title, carry?
Hon. Senators: Agreed.
The Chair: That has carried.
Shall the title carry?
Hon. Senators: Agreed.
The Chair: It’s agreed. The title has carried.
Shall the bill, as amended, carry?
Hon. Senators: Agreed.
The Chair: The bill, as amended, has carried.
Does the committee wish to consider appending observations to any report?
Hon. Senators: No.
The Chair: That’s agreed. We shall not have any observation.
Is it agreed that I, as chair, report this bill, as amended, to the Senate?
Hon. Senators: Agreed.
The Chair: That’s agreed. Thank you very much.
Colleagues, I think you have been very good in your questions and those questions were important because you received information that would have made it difficult to know exactly what we were dealing with in this particular case. I am convinced that you were able to sort it out and knew in the end exactly what we were dealing with.
I want to congratulate Senator Stewart Olsen for her patience, over a matter of months, in attempting to deal with all this. I extend our congratulations on behalf of the committee and I want to thank our officials from Health Canada again for being here. You were certainly helpful to us today, so thank you very much.
(The committee adjourned.)