Danish EPA list alternatives for DOP in medical applications

Last week the Danish EPA organized a conference in Copenhagen to present a paper on alternatives for DOP in medical applications. In Europe DOP has been phased out of most applications but is still widely used in medical applications. The last few years some replacement by other plasticizers was seen but still the majority sticked to DOP. It has to be said that from a technical point of view DOP simply performs very well, had a proven track record and was above all cost effective.
The combination of Arkema stopping DOP production and the increasing pressure on finding alternatives is creating a momentum in the medical industry to change and move to alternative plasticizers.
The Danish EPA did evaluate plasticizers which already are being used in medical applications and assesed if those were appropriate. Some of those plasticizers are already being used in medical applications for years but because of cost or availability issues their share remained small.
Products like DOA, TOTM, DOTP and hydrogenated DINP were evaluated and all were classfied as potential replacements for DOP.
This opens the door for change in the medical industry and is expected to speed up the phase out of DOP. There is enough free production capacity of the alternives to support the change and product costs are similar as DOP costs. The Danish EPA mentioned however, that although the mentioned products are considered to be safe for those applications, the producers need to close any data gaps. The plasticizer industry is known for commiting money and resources to close any data gaps and there is no doubt this will happen.

Promising future for DOTP

Only 5 years ago the European market for DOTP was estimated at a moderate 10kt. Since then a lot happened in the European plasticizer market and the volume did grow a tenfold at least.. The continious pressure on phthalates did move more and more customers to switch to (ortho)phthalate free plasticizers. At the beginning only those customers on the forefront of change did move to DOTP in order to be able offer (ortho)phthalate free products. More customers did follow but interesting enough even more suppliers did. The last 2 years one could easily state that the supply of DOTP was clearly bigger than the demand. Also structural low demand in Asia did motivate Asian suppliers to ship their product to EU in order to profit from the growing phthalate free market in EU. This over-supply did result in fierce competition which in turn did lead to DOTP becoming the most cost effective plasticizer available. And this in turn did trigger more growth…
The last few months the market became more balanced and a lot of customers learned that relying on imports alone can be a dangerous strategy. Yes, you can buy (ortho) phthalate free for a low price but if most of the supply is coming from outside of Europe it is really only a matter of time before supply issues occur.
In order to support the continious growth of DOTP it is therefore needed that in Europe the local capacity has to be increased significantly.
This is exactly what OXEA announced with its 50kt plant coming online in Q4 2015. Besides OXEA more EU suppliers are expected to increase capacity which in the end will ensure DOTP to remain to be very competitive but also to be more reliable from an availability point of view.

2014 More of the same?

2013 was a challenging year in the dynamic plasticizer industry. On the regulatory front there was good news for DINP. After extensive research and consultation ECHA concluded that no further restrictions are needed, basically declaring this phthalate plasticzer safe for use in all existing applications. However things are never easy and more confusion was created when suddenly DINP was added to the Californian Proposition 65 list. This means the state of California thinks the product causes cancer. Experts will know and confirm that the ECHA report is far more scientific based, but the media distributes all the news and everybody can guess themselves what kind of new gets more attention. More damage done to the reputation of phthalates.
On the supply side of things 2013 was also full of surprises. It felt like every month a new player was offering DOTP and this product did grow very well, especially in Europe. Arkema did announce to shut down their DOP plant which will trigger a shift away from DOP especially in the medical industry. This industry did stick to DOP as long as possible for various reasons. At the moment products like TOTM, DOTP and DINCH are replacing DOP increasingly in various applications.
With regard to new products it has to be noticed that bio based products are getting more attention, however the true sales volume will be rather limited due to performance, price and availability challenges. Benzoates also did get a lot of attention with companies like Emerald and Ferro investing heavily in capacity and apparently successfully.
In 2014 I unfortunenately expect more of the same. On the regulatory front conflicting messages will continue to be spreaded and not always will the scientific based message get the most attention. DOTP will continue to aggresively grow and replace traditional phthalate plasticizers. I also expect that bio based plasticizers will get more attention and perhaps this year also will get more volume behind them.

Tarkett announced to switch to phthalate free

Tarkett, worldwide leading flooring company, announced to move towards phthalate free products globally. This is meaning a huge change in the industry. Flooring is a high volume business for plasticizers and so far dominated by the use of phthalate plasticizers.
Tarkett was already using phthalate free plasticizers in North America and in Sweden. All the other European sides will follow in 2014 and the rest of the world will be next.
It is a fair assumption this will be a game changer in the industry. Many flooring companies will likely follow the market leader meaning an enormous boost for the already fast growing phthalate free plasticizers market. Roughly 100kt of plasticizers are now being used in the European (incl Russia) flooring production. If this will all move to phthalate free, this will change the landscape even quicker as people would have expected before. The phthalate free movement has three major growth drivers at the moment: 1) continuous pressure on phthalates, 2) good availability at competitive prices of phthalate free plasticizers and 3) industry leaders, like Tarkett, openly moving away from phthalates.

Plasticizer migration in medical devices

Picture1In general plasticizers can migrate out of PVC causing health concerns. In sensible applications therefore OXEA would recommend using plasticizers which show the least migration. This is the main reason TOTM is replacing DOP in some medical applications.
In medical devices not only PVC is used, also ABS, acrylic, Polycarbonate and Polystyrene are being used.
Teknor Apex did research if the potential migration of plasticizers could negatively impact the performance of these materials.
According to the study any potential migration can lead to softening, cracking and other defects in the non-PVC material.
Only TOTM was recommended for contact with the other materials.
The table was published in film & sheet extrusion, September 2013 issue.

Arkema to shutdown DOP production in March 2014. DOP supply in immediate danger!

Arkema will stop their DOP production in March 2014! Taking all the press releases the main reason for this seems mainly to be the continous pressure on the PA market. This market is oversupplied and with a low demand situation making some profit with this product is a challenge too much. In Chauny Arkema operates both PA and DOP production. Arkema is and was the main DOP producer in Europe. Certainly with regard to supplying the medical market Arkema is by far the most significant supplier.
DOP demand in Europe is declining for years now already,however the medical market was still strong and stable. DOP is under pressure but still has a signicant share in medical applications, especially in blood bags.
So far a lot of customers did resist change and did stick to DOP. However with the danger of not getting DOP anymore customers will decide to change the sooner the better.
DOP is already being replaced by other plasticizers in medical applications. For example TOTM did replace DOP in medical tubes. The combination of contineous regulatory pressure and now the uncertain supply situation will for sure motivate DOP customers to make a switch now. In most applications customers did already do their homework and did approve alternative plasticizers. Customers did stick to DOP because it was available, working well and alternatives were more expensive.

Danish to phase out phthalates in medical devices

On 27th of June the Danish Ministry of Health announced that the use of classified phthalates in medical devices should be phased out.

“We fully endorse Minister of Health Astrid Krag’s desire together with the other EU countries to phase out the classified phthalates from medical devices. We are in the Danish medical device industry advanced in phasing out classified phthalates in our products, and we will in the European association of medical device industries be advocating for a European phase out with a reasonable phase-out period. We have encouraged Astrid Krag to express the desire to phase out the use of classified phthalates in the negotiations on the new rules for medical devices, and we are very happy about the Minister’s positive opinion. We are also with great enthusiasm joining a collaboration project to identify new development and growth potential for phthalate-free medical devices “, said Peter Huntley, Director of Medicoindustrien .

PVC has a long and proven track record in the medical industry and at this time phthalate free plasticizers are available to replace the so called classified phthalates, which basically means DOP.
We already saw DOP being phased out in medical devices for some time now and this initiative will probably give another boost. PVC will remain the polymer of choice due to its proven performance, and also not unimportant, being most cost competitive. This will simply mean a further boost for the growth of phthalate free plasticizers.

The press release does state by the way that the goal is not to prohibit the use of clasisifed phthalates in medical devices because in particular cases this is not possible.

The question is what this will do with the future of DOP….medical devices is still a very important outlet for DOP and if it falls away one should wonder if this will mean the end of DOP…at least in the EU…

EU market flooded by DOTP…and more to come

As expected the big winner, so far, of the move towards phthalate free plasticizers is DOTP. This general purpose plasticizer shows an enormous growth and the growth curve seems to be even accelerating. It also looks if every day a new supplier/producer of DOTP emerges. Not so long ago the EU market size was moderate and supply was dominated by imports out USA, Korea and Turkey. OXEA was the first local EU supplier followed by ZAK, Ineos, Proviron and the list expands almost monthly. On top of that multiple producers in Turkey also launched DOTP and are entering the EU market.

This is all good news for customers who want to have a phthalate free plasticizer.
Finally the available EU capacity seems to be enough to enable a switch.

The expanding number of suppliers also ensures that competition is available and prices remain competitive. Although there seems to be enough capacity for producing DOTP, more capacity will come available. OXEA will start producing DOTP in second half of 2013 in Oberhausen, Germany, also, then having two plants producing DOTP in Europe.

Eastman did introduce DOTP years ago and was for a long time the sole supplier in the USA. Just recently BASF also launched DOTP in North America increasing the availability and with that also increasing the numbers of customers wanting to make the switch towards phthalate free.
DOTP demand in Asia was already huge and the number of suppliers sufficient but even in this region more capacity is coming online quickly and in more than sufficient quantities.

Taking this all into account nothing can stop DOTP becoming the winner of the phthalate free movement.

Update on TOTM Substance Evaluation

Oxea is manufacturing Oxsoft TOTM for several uses including medical devices. The excellent migration properties of TOTM make this molecule highly suitable for this type of application. TOTM is already used for years in medical devices, mainly medical tubing, and we see an increased demand for TOTM in this area because of concerns regarding DOP.
TOTM is currently undergoing the Substance Evaluation process under the REACH program. Currently the REACH registration dossiers have been evaluated by the designated Member State and the draft report is currently being discussed by ECHA and the other Member States. A final verdict is expected in autumn 2013.
TOTM was placed on the CoRAP because of its suspected PBT-properties. Based on available data, the Competent Authority was satisfied, that there is no concern regarding the Toxicity criterion. Further studies have been proposed to provide further data on persistence in the environment.
Oxea is committed to support any necessary research for missing data and to work closely with the Competent Authorities and co-producers in the further investigation into the product properties.
TOTM is outperforming other plasticizers like DOP, DOTP and hydrogenated DINP with regard to migration profile and therefore it has a promising future in applications where migration is a concern. This does not mean those products are not safe, not at all, it only means that TOTM has a superior migration profile. However it is important that the molecule TOTM is researched well and any missing data will be provided in order to tackle any future concerns and prevent any misunderstanding.

Phthalate free and bio based main trends

This week I attended the PVC Formulation conference in Düsseldorf, Germany. This conference gives a nice hollistic view of what kind of issues our customers are facing. This conference is not only around plasticizers but also around PVC itself, stabilizers and other additives.
In all presentations where plasticizers were mentioned it was eye-catching that terms like phthalate free and bio based were mentioned without any exception. It seems the industry did reckognize these trends are not going away and suppliers need to adapt their strategy.
Even the big major players are now moving in this direction. Evonik did announce to build a plant to produce hydrogenated DINP in Marl, Germany, and did publish a press release announcing phthalate free and even bio based plasticizers in the near future.
BASF, the market leader for hydrogenated DINP, did also recently launch DOTP in North America. Meaning now being able to offer 2 different kinds of general purpose phthalate free plasticizers.
Proviron and Petrom are working together to introduce bio based plasticizers in Europe, the PLS Green Range. From first sight those plasticizers have a promising performance and it is without a doubt that bio based plasticizers in general will get a bigger market share in future.
The bottomline is that the major trends of moving to phthalate free and/or bio based seems to be reinforced, both by customer demand and also by suppliers offering these products.

PVC & Plasticizers: What, Where & Why